Lead Regulatory Strategy Officer
3 weeks ago
Key Responsibilities:
- Oversee and strategize all regulatory initiatives across the product range.
- Serve as the primary regulatory liaison, collaborating with both internal teams and external partners.
- Develop Requests for Proposals and outline the scope of services for outsourced regulatory functions.
- Manage the evaluation and selection process for external regulatory service providers.
- Provide comprehensive global regulatory strategic guidance and operational assistance.
- Author, review, and manage essential regulatory documents for submission to regulatory authorities.
- Contribute to the planning and execution of regulatory strategies to ensure successful product development, including the drafting of development plans and Target Product Profiles.
- Support the creation of current Good Manufacturing Practices (cGMP) processes and controls, and prepare regulatory submissions for GMP audits.
- Maintain the regulatory document management system and ensure compliance through the creation and upkeep of key regulatory Standard Operating Procedures (SOPs).
- Engage in regulatory intelligence activities to stay abreast of industry trends.
Required Skills and Qualifications:
- A minimum of a Bachelor's degree in a life science, medical, or related discipline.
- At least 8 years of experience in regulatory affairs.
- Strong understanding of global regulatory standards for small molecules and biologics development.
- Proven expertise in drafting key regulatory documents such as Clinical Trial Applications (CTAs), Investigational New Drug applications (INDs), and development plans.
- Thorough knowledge of Good Practice (GXP) standards across development functions, as well as 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 solid understanding of evolving guidelines and regulatory trends.
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