- Developing and executing regulatory strategies aimed at securing and sustaining clinical trial applications
- Providing teams with regulatory guidance and input
- Supervising the development and submissions of regulatory filings within the defined scope of duties
- Remain up to date on any current regulations and guidance
- Bachelor's degree in life science related field; advanced degree in biomedical sciences or related fields is preferred
- Minimum of 10 years of experience in biopharmaceutical industry; 5 years of direct experience in regulatory strategy
- Experience in autoimmune disease
- Proven success with regulatory submissions such as IND, CTA, MAA, NDA, BLA
- Vast knowledge of regulatory guidelines of FDA, ICH, EMA, EU NCAs and other international agencies
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Regulatory Affairs Manager
3 weeks ago
Pharvaris Boston, United StatesPharvaris is a 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 ...
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Regulatory Affairs Director
3 weeks ago
Foundation Medicine Boston, United StatesJob Description · About the Job · The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI's unparalleled global portfolio of assay products, includ ...
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Regulatory Affairs Director
4 weeks ago
The Judge Group Boston, United StatesAbout the Job · The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMIs unparalleled global portfolio of assay products, including companion diagn ...
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Regulatory Affairs Manager
1 week ago
Pharvaris Boston, United StatesPharvaris is a 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 ...
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Regulatory Affairs Manager
4 weeks ago
Pharvaris Boston, United StatesPharvaris is a 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 ...
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Director, Regulatory Affairs
3 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...
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Head of Regulatory Affairs
2 weeks ago
Fairway Consulting Group Boston, United StatesOur client is a Non-profit organization. They have asked us to assist them in their search for a · Head of Regulatory Affairs. · Major tasks and responsibilities include: · Oversees regulatory strategies and operations interactions for entire portfolio. · Manages and improves r ...
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Regulatory Affairs Director
2 weeks ago
KP Recruiting Group Boston, United StatesJob Description · KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world's leading companies. Headquartered in the Midwest, KP Recruiting Group has successfully completed countless engagements across the United States. We rep ...
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Regulatory Affairs Specialist
1 week ago
Katalyst Healthcares and Life Sciences Boston, United StatesResponsibilities: · Interpret regulatory filings and lead cross-functional teams to comply with new or revised regulations. · Cultivate relationships within Customer Operations, throughout the Company and with external stakeholders. Partner with Corporate Affairs, Rate Engineeri ...
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Regulatory Affairs Specialist
3 weeks ago
Katalyst Healthcares and Life Sciences Boston, United StatesResponsibilities: Interpret regulatory filings and lead cross-functional teams to comply with new or revised regulations. · Cultivate relationships within Customer Operations, throughout the Company and with external stakeholders. Partner with Corporate Affairs, Rate Engineering ...
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Director, Regulatory Affairs
2 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovas ...
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Consultant, Regulatory Affairs
6 days ago
Halloran Consulting Group Boston, United StatesAre you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Hallorans Regulatory team in the Consultant, Regulatory Affairs role today · In this role, you will partner with client companies ...
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Head of Regulatory Affairs
2 weeks ago
Fairway Consulting Group Boston, United StatesOur client is a Non-profit organization. They have asked us to assist them in their search for a Head of Regulatory Affairs.Major tasks and responsibilities include:Oversees regulatory strategies and operations interactions for entire portfolio.Manages and improves regulatory doc ...
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Head of Regulatory Affairs
1 week ago
Discera Search Boston, United StatesLead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next. · Be the go for all things regulatory and acti ...
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Regulatory Affairs Associate
3 weeks ago
INTELLECTT INC Boston, United StatesRole: Regulatory Affairs Associate · Location: Remote · Duration: 7 Months · Main Responsibilities · Provide regulatory input to product lifecycle planning. Assist in SOP development and review. · Assist in the development of regional regulatory strategy and update strategy ...
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Consultant, Regulatory Affairs
1 week ago
Halloran Consulting Group Boston, United StatesAre you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran's Regulatory team in the Consultant, Regulatory Affairs role today · In this role, you will partner with client companie ...
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Director, Regulatory Affairs
3 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiova ...
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Regulatory Affairs Associate
3 weeks ago
White Collar Technologies, Inc Boston, United StatesJob Description · Job Description · Job Description · We 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 s ...
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Regulatory Affairs Representative
3 weeks ago
Vaco Boston, United StatesVaco has partnered with our client to hire a Regulatory Contractor for a month assignment. · Where: 100% Remote · When: Immediate need, 12+ month contract · Pay: $39-40/hour · Responsibilities:Responsible for providing regulatory content of label copy for all products. · Act ...
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Sr. Regulatory Affairs Specialist
1 week ago
Thrive Boston, United StatesA clinical-stage bio pharmaceutical client whose mission is to develop new therapies for people with rare diseases is looking for a Regulatory Affairs Specialist with pharmaceutical and/or biotechnology experience · The Regulatory Affairs Manager will support regulatory activiti ...
Senior Director Regulatory Affairs - Boston, United States - EPM Scientific
Description
Title: Senior Director, Clinical Regulatory Affairs
Salary: $250,000 to $285,000
Summary:
A clinical-stage biopharmaceutical client of ours is seeking a very experienced and motivated person to fill their Senior Director of Clinical Regulatory Affairs role in their facility located in the greater Boston area. The main functions of this person will be formulating regulatory strategies for both non-clinical and clinical domains, as well as spearheading engagements with regulatory bodies. This role will also give you a great opportunity to contribute to the clients' main missions which is to discover, develop, and commercialize therapies using their antibody technology.
The Senior Director will be responsible for...
The Senior Director should have the following qualifications: