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Global Head of Regulatory Affairs
2 months ago
Job Title: Global Head of Regulatory Affairs
Pharma Partners Recruitment Ltd is collaborating with a pioneering global pharmaceutical organization in search of a Global Head of Regulatory Affairs. This pivotal role involves providing strategic direction and oversight to the Regulatory Affairs division, focusing on the formulation and execution of regulatory strategies, objectives, policies, and initiatives from the initial stages of product development through to marketing authorization and ongoing lifecycle management.
Key Responsibilities:
- Direct the formulation of regulatory strategies and objectives that facilitate the successful registration and post-approval commercialization of the organization’s product pipeline.
- Establish and maintain productive relationships with regulatory authorities to ensure effective communication and outcomes, including scientific advisory meetings.
- Provide strategic regulatory leadership for the product portfolio, with comprehensive responsibility for developing, managing, and implementing the global regulatory affairs strategy for each product.
- Stay informed about global regulatory standards, assess potential risks, and devise contingency plans as necessary.
Qualifications:
- Significant regulatory experience in the field of innovative pharmaceuticals.
- A comprehensive understanding of drug development and commercialization processes, along with a solid grasp of GxP principles.
- Experience in a senior strategic role with decision-making authority.
- Demonstrated experience in line management.
Compensation and Benefits:
A competitive salary package along with an extensive benefits program is available for the right candidate.