Regulatory Strategy Leader
3 weeks ago
Key Responsibilities:
- Oversee and strategize all regulatory initiatives across the entire product line.
- Serve as the primary regulatory liaison, collaborating with both internal teams and external partners.
- Develop Requests for Proposals and outline the scope of outsourced regulatory services.
- Manage the evaluation and selection process for external regulatory service providers.
- Provide comprehensive global regulatory strategic guidance and operational assistance.
- Author, review, and manage critical regulatory documents for submission to regulatory authorities.
- Contribute to the formulation and execution of regulatory strategies to ensure successful product development, including drafting development plans and Target Product Profiles.
- Support the creation of cGMP manufacturing processes and controls, and prepare necessary regulatory documentation for GMP audits.
- Maintain the regulatory document management system and ensure compliance, including the development and upkeep of essential regulatory Standard Operating Procedures (SOPs).
- Engage in regulatory intelligence activities to stay informed on industry trends.
Qualifications and Skills:
- A minimum of a Bachelor's degree in a life science, medical, or a related discipline.
- At least 8 years of experience in regulatory affairs.
- Strong understanding of global regulatory standards for the development of small molecules and biologics.
- Proven expertise in drafting essential regulatory documents such as Clinical Trial Applications (CTAs), Investigational New Drug applications (INDs), and development plans.
- In-depth knowledge of GXP across development functions, ICH guidelines, and relevant regulations.
- Exceptional organizational, analytical, planning, and project management skills, with experience in overseeing external regulatory providers.
- Demonstrated capability to engage with key regulatory agencies and a thorough understanding of evolving guidelines and regulatory trends.
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