Associate Director

As a Associate Director, the work centres on developing a Local Regulatory Strategic Plan in collaboration with the RA personnel in the affiliates to elaborate the region’s position on specific projects. Act as ARPT lead. It would suit someone who can bring patience, clear communication, and respectful care standards to the role.

Where ownership sits

The incumbent’s decisions can affect sales, marketing, supply chain and clinical trials. Define and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds (early development, late development, marketed) for the Europe Region.

What the role carries

Develop a Local Regulatory Strategic Plan in collaboration with the RA personnel in the affiliates to elaborate the region’s position on specific projects. Act as ARPT lead. Identify and advocate region’s requirements in the overarching global regulatory strategy; develop risk assessment of the project(s) and make sure it is considered at the GRPT. Ensure regulatory compliance within Europe for assigned compounds/products. Implement remediation plan to address identified gaps, if any.

What helps the work land well

Handling shift-by-shift responsibilities with consistency and care. Strong professional approach.

What the role depends on

• Experience working in more than 1 therapy area with experience in immunology preferred.
• Experience in leadership of complex programmes with matrix reporting.
• Recent experience of managing agency meetings.

Practical details

• Additional detail: Training or development support may be provided.

Job details

• Benefits mentioned: Training