workable
Director, Regulatory Affairs
Allucent
Remote, GBR
Full-time
Senior · 8+ years experience
Remote
Discovered 1 weeks ago
Free
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As a Director of Regulatory Affairs, you will guide clients through the complexities of drug, biologic, and medical device development.
You will lead and mentor regulatory teams, shape strategies, and ensure the delivery of high-quality, scientifically sound submissions.
You will serve as a trusted expert in Health Authority (HA) interactions and translate regulatory requirements into clear, actionable plans.
In this role, you will act as a Subject Matter Expert, Technical Lead, or Consulting Lead across diverse project teams.
You will also review and author regulatory and scientific documents while driving successful outcomes for clients.
Most importantly, you will make a direct impact on advancing innovative therapies and global healthcare.
Your main responsibilities will include but not limited to:
• Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
• Reviews and prepares HA meeting requests and briefing documents.
• Oversees and manages regulatory projects of varying complexities.
• Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions.
• Has advanced knowledge of CTD format and structure for regulatory submissions.
Full Job Posting
Your main responsibilities will include but not limited to
- Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
- Reviews and prepares HA meeting requests and briefing documents.
- Oversees and manages regulatory projects of varying complexities.
- Provides strategic advice and expertise in translating regulatory requirements into practical plans and solutions.
- Has advanced knowledge of CTD format and structure for regulatory submissions.
About You
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