URGENT REMOTE HIRE - Director, Regulatory Affairs
Job Posting for URGENT REMOTE HIRE - Director, Regulatory Affairs at EPM Scientific
Remote Director of Regulatory Affairs - urgently hiring
Our client is looking to bring on a Director of Regulatory Affairs with previous experience in regulatory strategy. This person will work to develop and implement regulatory strategy for our client's biologics and endocannabinoid programs and will be responsible for regulatory submissions in support of our biologic assets in immune oncology. This person will be a key member of cross-functional teams and work with subject matter experts to establish development and regulatory strategy as well as finalization of study-related regulatory documents. Position will report to VP of Reg. Affairs.
Key Responsibilities:
- Serve as regulatory lead on development study teams as well as supporting sub-teams
- Develop effective regulatory strategies and ensure regulatory compliance within clinical and preclinical activities
- Collaborate with regulatory and cross-functional colleagues on clinical document preparation and reviews
- Lead negotiations with regulatory agencies to resolve issues and coordinate preparation and submission of responses to various Health Agency's questions
- Preparation and submission of regulatory filings
- Collaborate with study teams and keep study teams informed of the current regulatory environment and their impact on activities related to planned or ongoing studies
- Prepare and review sections of regulatory submissions for IND / CTA original submissions and amendments, orphan designations, and pediatric investigation plans
Sign up to receive alerts about other jobs with skills like those required for the URGENT REMOTE HIRE - Director, Regulatory Affairs.
Click the checkbox next to the jobs that you are interested in.
-
Auditing Skill
-
Income Estimation: $157,222 - $263,359
-
Income Estimation: $178,942 - $238,942
-
-
Compliance Management Skill
-
Income Estimation: $61,194 - $103,363
-
Income Estimation: $65,713 - $102,945
-
Job openings at EPM Scientific
Michigan, MI
Full Time
South San Francisco, CA
Full Time
Peachtree, GA
Full Time
Texas, TX
Full Time
Not the job you're looking for? Here are some other URGENT REMOTE HIRE - Director, Regulatory Affairs jobs in the Kodiak, AK area that may be a better fit.
We don't have any other URGENT REMOTE HIRE - Director, Regulatory Affairs jobs in the Kodiak, AK area right now.
Regulatory Affairs Associate (#856)
Dorsey & Whitney LLP, Anchorage, AK
Dorsey & Whitney LLP, Anchorage, AK