Head of Regulatory Affairs

Walker Cole International is searching for an experience Head of Regulatory Affairs to develop and manage a team and work across product development to life cycle maintenance to join an exciting global pharmaceutical business with a broad portfolio of small molecule and generic products.

A Head of Regulatory Affairs will:

• Develop and execute regulatory strategies for all products from development to commercial.
• Oversee the submission of new MAAs across EU/UK and globally
• Engage proactively with stakeholders, senior leaders, external experts, and consultants to support regulatory decision-making.
• Lead health authority interactions and scientific advice meetings.
• Manage interactions with Health Authorities to ensure feedback is incorporated into regulatory and product plans.
• Lead and develop a team.

A Head of Regulatory will have:

• Leadership abilities, experience managing a team.
• Experience working within EU procedures and HA interactions.
• Strong ability to work across multiple products and overseeing strategy from product development to life cycle management.
• Strong interpersonal skills and commercial acumen

Head of Regulatory // Senior Director // Regulatory Affairs // EU Submissions // International Submissions // CMC // Development // Life-cycle management // Small Molecule// Generics // OTC // Leadership //

…