Director Regulatory Affairs, Global Strategy & Submissions
Overview
Own global regulatory strategy and submissions for complex programs at scale. Lead interactions with regulatory authorities and drive fast-paced development programs. Collaborate with clinical, CMC, and external partners to accelerate timelines while maintaining compliance. This role differentiates by leading high-stakes INDs, CTAs, and BLA/MAA submissions in a multinational setting and by shaping regulatory pathways for expedited development.
What You'll Do10
- 1Build and lead global regulatory submissions for INDs CTAs BLAs/MAAs ensuring high quality packages and timely responses
- 2Drive regulatory strategic input for fast paced drug development including expedited pathways and agency interaction plans
- 3Own preparation planning coordination and review of submissions to global regulatory authorities
- 4Lead regulatory communications with stakeholders including planning and leading meetings with authorities
- 5Interpret and convey regulatory expectations to enable program objectives and ensure compliance with applicable regulations
- 6Maintain comprehensive understanding of regulations and guidelines to enhance regulatory success
- 7Represent Regulatory Affairs on global project teams and external alliances as needed
- 8Provide support to clinical study activities and interactions with CROs when required
- 9Contribute to policies procedures and best practices in a growing company
- 10Foster collaborative relationships with internal and external colleagues to ensure regulatory deliverables
Requirements10
- 1Bachelor's Degree in clinical scientific medical or industry related field required; Advanced degree preferred
- 2Minimum 2 3 years of U S regulatory experience
- 3Experience with biologics drug development and autoimmune disease especially inflammatory bowel disease
- 4Experience owning or supporting INDs and CTA experience
- 5Experience with BLA NDA MAA recent regulatory submissions
- 6Strong Microsoft Office skills and excellent document writing and formatting
- 7Experience with regulatory agency submission portals gateways
- 8Ability to work independently with minimal oversight and strong teamwork
- 9Experience with global Phase II or Phase III clinical trials
- 10Experience in early and late stage drug development
Salary Insight
$187 - $250k per year
Location
Required Skills
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