We have other current jobs related to this field that you can find below
-
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...
-
Director of Regulatory Affairs
1 day 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...
-
Director of Regulatory Affairs
16 hours 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...
-
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...
-
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...
-
Director, Regulatory Affairs, Advertizing
2 days ago
Boston, Massachusetts, United States Piper Companies Full timePiper Companies is seeking a seasoned professional to lead the Neurology Regulatory Affairs team as Director of Regulatory Affairs (Ad & Promo). Key Responsibilities:• Develop and implement regulatory strategies for advertising and promotional materials• Collaborate with cross-functional teams to create compliant labeling, advertising, and promotional...
-
Sr. Manager, Regulatory Affairs
3 weeks ago
Boston, United States The Judge Group Full timeAbout the Job The Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory approval process for FMI products. FMIs products include diagnostic assays that provide molecular insights to physicians to guide treatment options for cancer...
-
Sr. Manager, Regulatory Affairs
4 weeks ago
Boston, Massachusetts, United States Foundation Medicine, Inc. Full timeFoundation Medicine, Inc. Full TimeAbout the JobThe Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory approval process for FMI products. FMI's products include diagnostic assays that provide molecular insights to physicians to...
-
Sr. Manager, Regulatory Affairs
3 weeks ago
Boston, United States Foundation Medicine Full timeJob DescriptionAbout the Job The Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory approval process for FMI products. FMI's products include diagnostic assays that provide molecular insights to physicians to guide treatment...
-
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...
-
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...
-
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...
-
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...
-
Associate Director, Regulatory Affairs
1 day 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...
-
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...
-
Manager, Regulatory Affairs
3 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...
-
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...
-
Regulatory Affairs Associate
3 weeks ago
Boston, United States Katalyst HealthCares & Life Sciences Full timeJob 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...
-
Vice President Regulatory Affairs
1 day 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...
-
Vice President Regulatory Affairs
3 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...
![The Steely Group](https://media.trabajo.org/img/noimg.jpg)
Sr. Director, Regulatory Affairs
1 month ago
Responsibilities:
- Manages the planning, preparation, and submission of complex regulatory dossiers in support of project goals.
- Leads preparation of high-quality meeting packages, drives meeting strategy and team preparation.
- Contributes to the generation of policies and to the globalization of work processes.
- Maintains knowledge of US, EU and ICH regulatory requirements and guidelines and anticipates, assesses, and communicates changes in regulatory framework throughout the organization, as relevant.
- Keeps abreast of changing regulations and health authority actions, and applies knowledge to develop regulatory strategy for assigned projects in the region.
- Serves as a strategic regulatory leader for assigned drug development programs and uses extensive knowledge to advise project teams on regulatory requirements to drive successful global development strategies.
- Leads cross-functional teams to deliver high quality submissions, e.g., INDs, NDAs/BLAs, meeting requests and briefing documents, orphan applications, pediatric study plans, etc.
- Provides strategic direction and mentoring to staff, foster staff engagement and development.
- Serves as the primary liaison with Health Authorities for assigned products.
- Negotiates with Health Authorities, aid in the interpretation of Health Authority feedback.
- Builds relationships with internal and external stakeholders and integrates regulatory and drug development knowledge to facilitate ways of working and achievement of project and company goals.
Requirements:
- Bachelors degree in life sciences, Advanced degree preferred.
- 10+ years of relevant regulatory experience
- Oncology regulatory project leadership experience
- Experience managing staff
- Experience developing regulatory strategies for products intended to treat chronic diseases and products intended to treat severe, life-threatening diseases.
- Experience with document management systems, RIMS
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Strategic thinker, able to interpret complex regulations and apply them appropriately, throughout the product development lifecycle,
- Ability to quickly integrate information, define and mitigate risk, and prioritize activities among multiple projects.