Head of Regulatory Affairs
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Location
New York
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Sector:
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Job type:
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Salary:
$180,000- $200,000
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Contact:
Marissa Saunders
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Contact email:
m.saunders@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
about 1 year ago
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Expiry date:
2020-02-28
A commercialized Biotech client of ours in the rare disease space is looking for a Director of Regulatory Affairs to handle the regulatory affairs efforts for the organization. This position will report directly into the Head of R&D.
Responsibilities:
- File IND's, NDA's, and ensure compliance for their commercialized products
- Lead the Regulatory Affairs division and sit on the leadership team of the company
- Be responsible for post-approval and investigational regulatory submissions to the FDA
- Be responsible for submissions to foreign regulatory authorities such as the EMA
- Be the primary for approval responsibility of regulatory review for advertising and promoted materials of the company's commercialized products
- Chair the promotional review committee
- Serve as the primary contact with the FDA Office of Prescription Drug Promotion
- Collaborate cross functionally with other important stakeholders such as marketing, legal, and medical affairs
- Provide regulatory guidance in the preparation and creation of all regulatory documents
Requirements:
- 5-7 years of experience for review and approval of promotional and advertising materials for a US pharmaceutical company
- Demonstrated success for INDA and NDA regulatory submissions
- Bachelor's or other professional degree related to the pharmaceutical industry such as biology, chemistry, law, etc.
- Ability to work in a team environment
- Ability to work with computer systems to create and submit regulatory submissions
This role is actively interviewing, so if interested please feel free to contact Marissa at m.saunders@hamlynwilliams.com