Global Regulatory Submissions Leader

Ipsen Pharma (SAS); Holmfirth; Hybrid; GBP 80,000 - 110,000; Full time

Job summary

A global biopharmaceutical leader is seeking a Head of Regulatory Submission Project Management in the UK. This role involves leading a unified project management organization for regulatory submissions, ensuring quality and timely delivery. Candidates should have 10-15 years of experience in regulatory affairs or project management within the pharmaceutical industry, along with a bachelor's degree in a scientific discipline. Join us in impacting patient outcomes through innovative therapies.

Qualifications

• 10-15 years of experience in Regulatory Affairs/Pharmaceutical Project Management.
• Experience leading international regulatory submissions (IND, NDA, MAA).
• Strong experience managing complex products across multiple regions.

Responsibilities

• Provide strategic and operational leadership for Regulatory Project Management.
• Ensure high-quality, timely delivery of regulatory submissions.
• Oversee priority submissions and collaborate with cross-functional teams.

Skills

Pharmaceutical Project Management

Regulatory Affairs

Leadership

Critical path management

Scenario planning

Risk management

Fluent English

Education

Bachelor's degree in a scientific discipline

Job description

A global biopharmaceutical leader is seeking a Head of Regulatory Submission Project Management in the UK. This role involves leading a unified project management organization for regulatory submissions, ensuring quality and timely delivery. Candidates should have 10-15 years of experience in regulatory affairs or project management within the pharmaceutical industry, along with a bachelor's degree in a scientific discipline. Join us in impacting patient outcomes through innovative therapies.