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Regulatory Affairs Associate
4 weeks ago
Job Description Responsibilities: This position will assist with the preparation and submission of ANDAs, Amendments, Supplements and Annual Reports to appropriate regulatory agencies. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Works with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups, Information Technology, and other departments as needed. May submit submissions for changes to labeling, QC, manufacturing, or distribution practices. Keeps abreast of regulatory compliance issues and assist in developing new Regulatory Department procedures, as needed. Prepare, assemble, review and/or evaluate, publish and archive new ANDA and life cycle management regulatory submissions in accordance with local regulatory requirements and guidelines. Prepare paper based and electronic submissions, including both eCTD and non-eCTD formats, for multiple projects to regulatory agencies, and ensure the timely delivery of quality submissions. Critically review submission documentation and provide input to respective departments for necessary revisions. Coordinate and prepare responses to FDA Deficiency Letters and other agency requests. Using eCTDXpress complete submission publishing for submission through ESG. Qualifications: BS or MS in scientific discipline or equivalent education and experience. Minimum 3 years previous work experience in the pharmaceutical industry, preferably in the area of drug regulatory affairs, analytical, QA, R&D or production experience. Must have a working knowledge of US Regulatory Submissions. #J-18808-Ljbffr
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Director of Regulatory Affairs
3 days ago
boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
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Director of Regulatory Affairs
1 week ago
Boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
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Director of Regulatory Affairs
4 days ago
boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
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Director of Regulatory Affairs
2 weeks ago
Boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
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Director of Regulatory Affairs
3 months ago
Boston, United States JRG Partners Full timeJob DescriptionJob DescriptionJob Title: Director of Regulatory AffairsJob Description:As the Director of Regulatory Affairs in the medical device industry, you will play a pivotal role in ensuring that our products comply with all applicable regulatory requirements and standards. Leveraging your extensive knowledge of regulatory processes, you will lead the...
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Regulatory Affairs Specialist
4 weeks ago
Boston, United States Myomo, Inc. Full timeHave you ever felt blown away by the miracles of modern medicine, while also feeling that the patient experience still leaves much to be desired?Here at Myomo, Inc., it's our mission not only to leverage the power of cutting-edge robotic technology to improve patient quality of life, but also to demonstrate a commitment to prioritize and serve the patient.We...
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Regulatory Affairs Specialist
4 weeks ago
Boston, United States Myomo, Inc. Full timeHave you ever felt blown away by the miracles of modern medicine, while also feeling that the patient experience still leaves much to be desired?Here at Myomo, Inc., it's our mission not only to leverage the power of cutting-edge robotic technology to improve patient quality of life, but also to demonstrate a commitment to prioritize and serve the patient.We...
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Regulatory Affairs Associate
3 months ago
Boston, United States WHITE COLLAR TECHNOLOGIES INC Full timeJob DescriptionJob DescriptionJob DescriptionWe have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. All of these roles will interface with clients on different projects to provide consulting services.We are seeking entry-level experienced personnel or fresh graduate students willing...
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Manager, Regulatory Affairs
5 days ago
Boston, United States Foundation Medicine Full timeAbout the JobThe Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The incumbent functions as the regulatory representative on cross-functional teams...
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Associate Director, Regulatory Affairs CMC Writer
2 months ago
Boston, United States Pharvaris Full timePharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple...
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Associate Director, Regulatory Affairs CMC Writer
2 months ago
Boston, United States Pharvaris Full timePharvaris is a Nasdaq listed late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple...
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Associate Director, Regulatory Affairs
4 weeks ago
Boston, United States Monte Rosa Therapeutics Full timeAssociate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...
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Associate Director, Regulatory Affairs
1 month ago
Boston, United States Monte Rosa Therapeutics Full timeAssociate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...
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Associate Director, Regulatory Affairs
1 month ago
Boston, United States Monte Rosa Therapeutics Full timeAssociate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...
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Associate Director, Regulatory Affairs
4 days ago
boston, United States Monte Rosa Therapeutics Full timeAssociate Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be...
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Regulatory Affairs Specialist
1 month ago
Boston, United States BRIOHEALTH SOLUTIONS INC Full timeJob DescriptionJob DescriptionBrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Regulatory Affairs Specialist to join our growing team. As a regulatory affairs specialist at BrioHealth Solutions Inc., you’ll support product development activities for Class III Medical Devices and have responsibility for preparing and submitting FDA...
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Vice President Regulatory Affairs
4 days ago
Boston, United States Scienta Full timeJob Title: Global Vice President of Regulatory AffairsLocation: United States (Flexible/Remote)Reports to: Chief Medical Officer (CMO)Department: Regulatory AffairsPosition Type: Full-Time, Executive LevelScienta Search is seeking a seasoned and strategic leader to join our executive team as the Global Vice President of Regulatory Affairs. This position will...
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Vice President Regulatory Affairs
4 days ago
boston, United States Scienta Full timeJob Title: Global Vice President of Regulatory AffairsLocation: United States (Flexible/Remote)Reports to: Chief Medical Officer (CMO)Department: Regulatory AffairsPosition Type: Full-Time, Executive LevelScienta Search is seeking a seasoned and strategic leader to join our executive team as the Global Vice President of Regulatory Affairs. This position will...
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Vice President Regulatory Affairs
5 days ago
Boston, United States Scienta Full timeJob Title: Global Vice President of Regulatory AffairsLocation: United States (Flexible/Remote)Reports to: Chief Medical Officer (CMO)Department: Regulatory AffairsPosition Type: Full-Time, Executive LevelScienta Search is seeking a seasoned and strategic leader to join our executive team as the Global Vice President of Regulatory Affairs. This position will...
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Director, Regulatory Affairs
6 hours ago
Boston, United States Fairway Consulting Group Full timeOur client is a clinical stage biopharmaceutical company. They have asked us to assist them in their search for a Director, Regulatory Affairs. Major tasks and responsibilities include:Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory...