Director, Regulatory Affairs Strategy
The Director of Regulatory Affairs Strategy will be responsible for developing and implementing comprehensive regulatory strategies to ensure compliance with global regulations while supporting the organizations business objectives. This role requires a deep understanding of regulatory requirements across various markets, particularly in pharmaceuticals and medical devices.
Main Responsibilities
- Lead the creation and execution of regulatory strategies that align with the company's goals for product development and market approval.
- Oversee the preparation, review, and submission of regulatory documents including INDs, BLAs, NDAs, PMAs, and other necessary filings to health authorities.
- Cross Functional Collaboration: Work closely with R&D, Quality Assurance, Manufacturing, and Commercial teams to ensure alignment on regulatory requirements throughout the product lifecycle.
- Stakeholder engagement: Serve as the primary liaison between the organization and regulatory agencies, ensuring effective communication and collaboration.
- Provide training to internal teams on regulatory requirements and best practices to foster a culture of compliance within the organization.
Profile
- Bachelors degree in life sciences (pharmacy, biology, chemistry) or related field; advanced degree preferred.
- Experience in regulatory affairs within the pharmaceutical or medical device industry
- Leadership experience preferred.
- Strong project management skills; proven ability to work collaboratively in a cross-functional environment.
Benefits
- Competitive salary, bonus and attractive packages
- Remote working
- Excellent company culture
- Professional career growth opportunities
- Exposure to a dynamic and evolving Biotech company