Full-Time Associate Director, Regulatory Affairs
Deciphera Pharmaceuticals is hiring a remote Full-Time Associate Director, Regulatory Affairs. The career level for this job opening is Manager and is accepting Waltham, MA based applicants remotely. Read complete job description before applying.
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Deciphera Pharmaceuticals
Job Title
Associate Director, Regulatory Affairs
Posted
Career Level
Full-Time
Career Level
Manager
Locations Accepted
Waltham, MA
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Job Details
The Role: The Associate/Director, Regulatory Affairs will join a highly motivated team, shaping regulatory strategies for oncology products through development phases.
What You’ll Do:
- Develop regulatory strategies for oncology programs (from FIH to post-marketing).
- Provide regulatory solutions and guidance to cross-functional teams.
- Monitor global regulatory changes affecting asset development.
- Offer tactical support and operational expertise.
- Ensure compliance of regulatory strategies and submissions.
- Assess project plans and timelines; manage staff.
- Contribute to process improvement.
What You’ll Bring:
Required Qualifications:
- B.S./M.S. and 8+ years of regulatory affairs experience in pharmaceuticals.
- 5+ years of global development and submission experience.
- Advanced knowledge of oncology drug development regulations (US and EU).
- Experience filing INDs and/or NDAs with FDA and other regulatory bodies.
Preferred Qualifications:
- Strategic thinking and innovative problem-solving skills.
- Strong verbal and written communication skills.
- Regulatory team management experience.
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Associate Director, Regulatory Affairs at Deciphera Pharmaceuticals is
19th of January 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Waltham, MA
] applicants. .
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