Easily apply. Some of the most common tasks and responsibilities of regulatory specialists include: Maintaining a deep understanding of new and existing regulations that may impact their organization's products and processes Using that understanding to standardize all business operations and establish clear, documented protocols Regulatory Affairs Specialist duties and responsibilities Ensuring compliance with all regulatory requirements Maintaining regulatory documentation database Assisting with the preparation and submission of all regulatory reports Providing accurate reviews of data and reports Ensuring accurate and timely submissions to regulatory agencies Managers can earn in the region of £50,000 to £70,000. A job in regulatory affairs will require at least a bachelor's degree in a field related to the industry, such as science, business, economics, or law. Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. Regulatory Affairs Associate. Regulatory Affair Associate Job Responsibilities and Duties: Ensure that a company's business conforms with the requirements of the location in which it wishes to sell it Stay current on national laws, regulations, and client habits. . regulatory affair jobs 1-30 of 47 jobs Senior Regulatory Affairs Specialist (Cosmetics/ personal care) Adecco Recruitment (Thailand) Limited Bangkok Area - Samutprakarn Cosmetics experience manufacturer Thai FDA process 1d ago Job Functions Beauty Care / Health / Others Job Type Full Time Adecco Recruitment (Thailand) Limited jobs Here is what they said. Create and write coherent justifications and reasons for new product licenses Il candidato/a verrà inserito all'interno del dipartimento Pharmaceutical Affairs, e supporteà il team nelle attività finalizzate al mantenimento . Summary: The Principal Regulatory Affairs Specialist who will be responsible for developing and driving the timely preparation of US & EU regulatory submissions and collaborating with international partners. Full-time. Director: $189,000. Coordinated with regulatory agencies to facilitate cooperation. Regulatory Affairs Specialist/Analyst Resume. These will include performing formula . Building on a legacy of innovation gives my work purpose . Sciences. Trinity Biotech's continued success is based on the fact that as a . Skip to refine results. According to the Regulatory Affairs Professional Society's (RAPS) 2018 report, the national average total compensation for U.S.-based regulatory professionals by job level is: Vice President: $256,500. Finding your dream job as a regulatory affairs manager - with Hays. Regulatory Affairs Manager Job Description Sample Template. TOPRA is a professional association for people working in the field. Regulatory Affairs Jobs. Skills : Communication Skills, MS-Office. A regulatory affairs officer needs to wear a lot of different hats, so to speak. As of 2016, the average yearly salary for regulatory professionals at all levels was $150,422. Job Description. Regulatory Affairs Executive - Basic Up $4200 / 5Days / Bonuses. /. Most consultants specialize in one or two industries instead of offering services to every business. 1921 global regulatory affairs manager Jobs. Regulatory Affairs Manager. Job Outlook Very Good. Assists in developing procedures to ensure regulatory compliance. Job Description Summary Job DescriptionBe part of something bigger!BD is one of the largest global…See this and similar jobs on LinkedIn. Our company is looking for a Senior Regulatory Affairs Specialist to join our team. The profession offers opportunities for travel and international employment. The average Regulatory Affairs Specialist salary in the United States is $185,274 as of December 27, 2021. Posted. Director, Regulatory Affairs Qualifications Qualifications for a job description may include education, certification, and experience. Director of Quality & Regulatory Affairs. We asked Regulatory Affairs Managers how satisfied they are with their job. $58K - $110K (Glassdoor est.) The term "regulatory affairs administrator" might refer to several different positions within industries that are regulated by federal, state or local agencies, such as health care, banking and energy. Participate in design projects as an independent reviewer. The position of the Sr. Regulatory Affairs Specialist in Personal Care reports to the Sr. Apply to Director of Regulatory Affairs, Clinical Associate, Associate and more! Job Specializations. at Cordis in Augusta, Maine, United States Job Description. LinkedIn Senior Regulatory Affairs Specialist in Moses . £25,000 - £29,000 a year. 90 AbbVie Regulatory Affairs jobs. Regulatory Affairs Specialist. The physical demands described here are representative of those that must be met by an employee to 2) Coordinate efforts associated with the preparation of regulatory documents or submissions. Experience in regulatory affairs of OTC products. 8 days ago. The CPI Group 4.2. Regulatory Affairs Specialist. To support clients by providing regulatory review and technical input, developing and contributing to regulatory documentation. Ensures that project/department milestones/goals are met and adhering to approved budgets. Employer. Keep in mind that salary ranges can vary widely depending on many important factors, including position, education, certifications, additional skills, and . MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. 2 • 2+ years of experience in medical device. Experience in regulatory affairs related to the chemical distribution field. Woodley Bio Reg. Job Description Form Job Title: Senior Regulatory Affairs Specialist Department: RA/CA/QA Reports to: Director of Regulatory Affairs (TBD) Status: X Exempt Nonexempt As a Senior Regulatory Affairs Specialist with this fast growing, Class II medical device company, you will be responsible for product submissions, license renewals, periodic . Our vision is to be the trusted industry leader in worldwide regulatory solutions. Job Duties and Tasks for: "Regulatory Affairs Manager" 1) Provide responses to regulatory agencies regarding product information or issues. 87 jobs available on BioSpace, The Home of the Life Sciences Industry. 30d+. Here is what they said. Oakville, ON • Temporarily Remote. Rate of Pay: Dependent on experience. Assist in fulfilling requirements of the Person Responsible for Regulatory Compliance under the EU MDR 2017/745. Regulatory affairs officer: job description Regulatory affairs officers act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation. The U.S. Bureau of Labor Statistics (BLS) classifies regulatory affairs managers with 'managers, all other' in their employment statistics. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Analyzed product development and research, monitored for legislative and regulation updates to ensure compliance. That's the core focus for our global Regulatory Affairs team. Participate in internal audit program. Has full authority for personnel actions. Featured Schools Job Description. Regulatory Affairs Coordinator. Those starting in assistant and junior roles might command salaries between £18,000 and £24,000, whilst regulatory affairs officers with more experience are looking at yearly earnings between £28,000 and £50,000. This position supports the Regulatory Affairs department within M&T Bank Corporation's Risk Management & Regulatory Affairs Division ("Risk Division"). They need to stay updated on the laws and regulations that govern their particular segment of the biotech industry in order to ensure that the company's products meet and pass them. Confluent Medical Technologies INC. Job Tasks. Regulatory Product Manager. You are • A combination of education, experience, leadership, strategy and QA/RA influence may be considered. Strong industry experience, technology-enabled services, and a data . Responsibilities: Assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations; Senior Regulatory Affairs Specialist Job Description Template. PayScale reported a median annual income of $103,474 for regulatory affairs managers in 2020. Regulatory Affairs Associate Job Description Regulatory affairs associates are often employed by pharmaceutical or medical devices companies, and assist in obtaining government approval for drugs,. The major duties, tasks, and responsibilities that typically make up the regulatory affairs specialist job description are listed below: Explaining regulations, policies, or procedures Ensuring adequate compliance with regulations Advising others on matters that are related to regulatory processes and compliance Job Description: Head of QA and RA Job Description for the position of Head of Quality Assurance and Regulatory Affairs Location: Bray, Co. Wicklow, Ireland Company Overview: Trinity Biotech specialises in the development, manufacture and marketing of diagnostic test kits. The regulatory affairs compliance jobs have to clearly define the regulatory requirements necessary to gain approval for commercialization from the regulatory agencies. The range for our most popular Regulatory Affairs Specialist positions (listed below) typically falls between $55,063 and $315,484. Job description. They may work in a variety of industries, including automotive component and tool manufacturing companies. /. Manager Quality, Regulatory Affairs. Principal Scientist/Director - Regulatory Affairs - CMC. Job Summary: In this role, you will be responsible for applying human factors and usability engineering methods throughout the design and development processes for West's Products, coordinating regulatory submissions for West's products and processes support West customers regulatory activities and maintain knowledge of current US and . Works independently under limited supervision. JOB DESCRIPTION - QUALITY ASSURANCE AND REGULATORY AFFAIRS SPECIALIST 8. Description Company Background knoell is a global company headquartered out of Germany that researches, processes and evaluates scientific data across all scientific specialties. 3) Analyze product complaints and make recommendations regarding their reportability. Being a Regulatory Affairs Director requires a bachelor's degree. JOB DESCRIPTION -Regulatory Affairs Specialist 11. In this role, you will oversee regulatory submissions, ensuring they are compliant with regulations as well as the guidelines set by regulatory . General Description and Duties: To perform this job successfully, an individual must be able to perform . Regulatory Affairs Director, June 2004 to May 2009. Average Salary $68,294. Boston, Massachusetts, United States of America. This position will entail ensuring the compliance of personal care products in the countries that Arbonne does business in. Job satisfaction 70% How meaningful is this job 47% 70% of them said they were satisfied with their job and 47% said they find that their job makes the world a better place or helps to make someone else's life better. Direct the preparation and submission of regulatory agency applications, reports, or correspondence. View details. 1,590 Senior Associate Regulatory Affairs jobs available on Indeed.com. Job Description of a Regulatory Affairs Officer. Positions within regulatory affairs offer excellent job security. The position of Regulatory & Legal Affairs Manager works under the direction of the President/CEO to manage issues related to local, state, and federal regulations and regulatory programs affecting the oil and gas industry in Alaska, with a particular focus on environmental 7 days ago. . Provide the best regulatory strategy in compliance with local and international regulatory requirements for…. + Regulatory intelligence - identification . Extensive knowledge of department processes. Fulfilling the responsibilities of a regulatory affairs consultant role requires presentation skills, research skills, familiarity with regulatory processes, and the ability to maintain any job-specific or industry-specific qualifications. 9. Review and approve product change orders and deviations, considering regulatory impact of proposed . The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. Description Enabled; SAP as service provider: We use the following session cookies, which . Job Description Summary: The Director, Regulatory Affairs - CMC (Drugs) is responsible for providing regulatory leadership in Chemistry, Manufacturing and Control (CMC) for PTC's pharmaceutical products, including: leading the CMC regulatory strategy development and implementation that incorporates risk identification and mitigation for programs at various stages of product life cycle . MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Manager and will work closely with Product Development and Marketing. Maintain current knowledge of relevant regulations, including proposed and final rules. Our reputation for excellence hinges on staying current in a constantly evolving regulatory environment. The Organisation for Professionals in Regulatory Affairs explains on its website that a regulatory affairs department ensures that the firm adheres to state and federal laws protecting public health. Physical Demands . Job Types: Full-time, Permanent. Oversight of Full Product Life Cycle Manage control system activities in organizations. We are recruiting a Regulatory Affairs Manager to provide support to our pharmaceutical and medical device company. Redditch B98 0RE. Years Higher Education 4 - 6. Salaries for specialist or experienced regulatory affairs professionals (three to five years' experience) typically range from £40,000 to £50,000. 14. As a highly qualified regulatory affairs manager, you contribute both your specialist knowledge and your broad range of qualifications and skills to your employer's success. Job available in 4 locations. Objective : A versatile regulatory and compliance professional with experience in NDA, IND and submissions for drug and medical devices to the FDA and other international health authorities. Milpharm Ltd. Ruislip HA4 6QD. Employers looking to fill senior positions will prefer candidates with a master's degree and extensive experience in consulting, law, and regulatory affairs. The job requirements are: -Bachelor degree in a relevant discipline as related to the organization one wants to work in. North Wales, Pennsylvania, United States of America. Associate Director, GRACS Devices & Digital Health. This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with EU, HC, TGA, UKCA regulations, ISO standards, and other regulatory agencies. Download Resume PDF Build Free Resume. Although the specific duties of a regulatory affairs . The regulatory affairs department will often take part in the development of product marketing concepts and is commonly required to approve packaging and advertising before it is used commercially; This Pharmacy Regulatory Affairs Career Description is a part of The Ultimate Guide to Pharmacy Careers, part of our future book, POTENTIAL. Easy Apply. We asked Regulatory Affairs Specialists how satisfied they are with their job. Strong industry experience, technology-enabled services, and a data . Next: View Schools Diploma in regulatory affairs an asset. Job Overview Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. If you want to boost your career, Hays is the perfect point of contact. Regulatory compliance specialists ensure that organizations comply with industry specifications, standards, regulations, and laws. De Kalb, MS. $130,000 - $140,000 a year. MCI Career Services Pte Ltd. North-East, East SGD 3K - 4.2K monthly. 3.2. Internship Regulatory Affairs. A job in regulatory affairs will require at least a bachelor's degree in a field related to the industry, such as science, business, economics, or law. They are often employed by pharmaceutical, biotechnology, and medical device . --- Because you belong at Twilio The Who, What, Why and Where Twilio is seeking a Telecom Regulatory Affairs Analyst to help support our telecommunications regulatory function within our legal team. Maintain QMS procedures related to regulatory responsibilities, product licensing, and regulatory reporting. A regulatory affairs specialist has a number of duties, including collecting and analyzing data, computer processing, creating and maintaining records, developing new regulatory strategies, completing administrative duties and more. 1. 13. Since every step in the process of product development is highly regulated, those in RA work at each step to move a drug from research and development through FDA approval. Regulatory Affairs Director, July 2009 to Present. Skip to job results. 9d ago. Regulatory Compliance Specialist Job Description Learn about the key requirements, duties, responsibilities, and skills that should be in a regulatory compliance specialist job description. A primary job responsibility for regulatory affairs specialists is evaluating current and new products for compliance with applicable regulations. 18 days ago. Chemistry. 3) Coordinate internal discoveries and depositions with legal department staff. True first level manager. Maintain records of tasks and registered product information in the internal regulatory databases. -Minimum 3 years' regulatory experience in any industry. From 2019 to 2029 the BLS expects managers in this group to see job decline of 2%. Austin, TX. Jobs at the Office of Regulatory Affairs (ORA) At ORA, you make a difference in protecting the health of the American people. This individual will serve as a regulatory core team lead and provide ongoing regulatory guidance to the project teams. To be successful in this . Assess and document regulatory impact of product design changes in jurisdictions where product is licensed. Manager, Regulatory Affairs (CMC) Job Code 481LL Description Fate Therapeutics is seeking an experienced and highly motivated regulatory professional to support its expanding cellular therapy programs. New Regulatory Affairs Manager jobs added daily. Regulatory Affairs Director directs the regulation process for products requiring governmental approval by ensuring that all necessary applications are filed and handling all government interactions. ORA has an ongoing need for qualified individuals with backgrounds in . 12. This template is provided for informational purposes only. Barentz. Regulatory Affairs Officer. Find Regulatory Affairs jobs in Biotechnology. Regulatory affairs (RA) scientists are involved with overseeing the process of getting a drug or product through the FDA review and approval process and onto the market. Download Job Description. Huddersfield, West Yorkshire. There are plenty of opportunities to land a Regulatory Affairs Specialist job position, but it won't just be handed to you. Job Description - Sr Regulatory Affairs Specialist . Regulatory Affairs is responsible for: + Supervisory exam management, continuous monitoring, and regulatory relations. The Manager, Regulatory Affairs (RA) will provide support to the Associate Director, RA in the development and implementation of global Chemistry, Many of these tasks must be accomplished at once and sometimes in groups, so multi-tasking and communication are . Company Name City, State. Regulatory Affairs Assistant. Lexon (UK) Ltd 2.8. The ultimate responsibility for selecting an accurate and non-misleading job title and description, and ensuring that a job posting does not otherwise violate any . Leverage your professional network, and get hired. Licensing or Certifications for Director, Regulatory Affairs List any licenses or certifications required by the position: RAC, FEMA, RAPS, TFD, ASQ, CMC, US, CE, IV, QMS Education for Director, Regulatory Affairs Regulatory Affairs Associate. Regulatory Affairs Assistant required to work with…. Apply now for Telecom Regulatory Affairs Analyst job at Twilio in Amsterdam, Netherlands. 2) Train staff in regulatory policies or procedures. Job Description Form Job Title: Senior Regulatory Affairs Specialist Department: RA/CA/QA Reports to: Director of Regulatory Affairs (TBD) Status: X Exempt Nonexempt As a Senior Regulatory Affairs Specialist with this fast growing, Class II medical device company, you will be responsible for product submissions, license renewals, periodic . Download Regulatory Affairs Manager Job Description Now! Job Type. Job Duties and Tasks for: "Regulatory Affairs Specialist" 1) Compile and maintain regulatory documentation databases or systems. Regulatory Affairs Specialist. $48,000 - $55,000 a year. 331890BR Nov 11, 2021 Italy Job Description Siamo alla ricerca di un/a giovane laureand*/laureat* in discipline scientifiche da inserire nel nostro team. The Job Duties of a Regulatory Affairs Administrator. Hours: Mon - Thurs 0800 - 1700 Fri 0815 - 1600 (40 hours per week). Collected and processed corporate data. ZipRecruiter is the Smartest Way to Hire Post Jobs for Free . Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. The reason is simply supply and demand: not enough people today have experience in regulatory affairs and at the same time, the FDA has increased its standards, requiring more supporting studies and paperwork before products can be approved for human use. Posted. Up to £70,000 DOE and Specialism. Employers looking to fill senior positions will prefer candidates with a master's degree and extensive experience in consulting, law, and regulatory affairs. Description:Fate Therapeutics is seeking an experienced and highly motivated regulatory professional to support its expanding cellular therapy progra. Knowledge of Many Different Subjects. Crafting a Regulatory Affairs Specialist resume that catches the attention of hiring managers is paramount to getting the job, and LiveCareer is here to help you stand out from the competition. Full time. Essential Functions Regulatory affairs specialists usually work full-time in an office environment. Description. Search job openings, see if they fit - company salaries, reviews, and more posted by AbbVie employees. Salaries for those with extensive experience, for example at associate director or director level, can rise to in excess £100,000. With appropriate support from senior team members/manager …. Job ID. Today's top 4,000+ Regulatory Affairs Manager jobs in United States. Need for qualified individuals with backgrounds in -minimum 3 years & # x27 ; s.. Affairs is Responsible for regulatory Affairs officer needs to wear a lot different! Successfully, an individual must be able to perform serve as a regulatory Affairs | Novartis < /a apply..., accuracy, comprehensiveness, or compliance with regulatory standards submissions, ensuring they are compliant with regulations as as... Legacy of innovation gives my work purpose influence may be considered several years of experience medical. Job requirements are: -Bachelor degree in a variety of industries, including proposed final. 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