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Senior Director, Clinical Regulatory Affairs
Posted 3 months agoViewed
💎 Seniority level: Director, 12-15+ years
💸 Salary: 275000.0 - 305000.0 USD per year
🔍 Industry: Biotechnology
🏢 Company: Arcellx👥 101-250💰 $200,000,000 Post-IPO Equity over 1 year agoPharmaceuticalBiotechnologyBiopharmaLife ScienceHealth Care
🗣️ Languages: English
⏳ Experience: 12-15+ years
Requirements:
- BSc in natural or health sciences (biology, pharmaceutical sciences, or equivalent).
- 12-15+ years of clinical regulatory affairs experience, including early and late phase research, with strong knowledge of health authority regulations and guidance.
- Proficiency directly writing submission documents that support clinical trials, marketing applications, and lifecycle management.
- Experience interacting with Health Authorities and reviewing materials to ensure compliance with applicable regulatory laws and guidance.
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.
- Exceptional project management skills, organizational and problem-solving skills.
- Eager to learn with a collaborative, team-oriented mindset.
- Excellent written and verbal communication skills.
Responsibilities:
- Develop and execute global clinical regulatory strategies.
- Lead program teams in preparing regulatory submissions including briefing documents, IND/CTA/BLA filings, and marketing applications.
- Oversee strategy and drafting of documents related to interactions with regulatory authority on clinical matters.
- Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine.
- Support internal clinical and development teams to provide direction on global regulations and guidance.
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