Associate Director, Regulatory Affairs
A pioneering biopharmaceutical company is seeking an Associate Director, Regulatory Affairs to lead global clinical trial application (CTA) strategy and regulatory compliance efforts. This organization is leveraging revolutionary technology at the intersection of chemistry, engineering, computation, and biology to unlock novel drug targets.
Key Responsibilities:
- Develop and execute global CTA submission strategies across Europe, LATAM, APAC, and ROW
- Ensure compliance with evolving ex-US regulations (EU-CTR, ICH, country-specific)
- Collaborate cross-functionally with Clinical Operations, CMC, Supply Chain, and more
- Liaise with global regulatory agencies and manage submission platforms (CTIS, IRIS)
- Oversee regulatory aspects of GCP, GDPR, and quality systems
- Identify and mitigate regulatory risks across programs
Qualifications:
- 8+ years in Regulatory Affairs with global CTA experience
- Strong knowledge of international regulatory frameworks and submission platforms
- Excellent communication, project management, and cross-functional collaboration skills
- Comfortable in a fast-paced, high-growth biotech environment
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