Global Regulatory Submissions Lead

Ipsen Biopharm Ltd; Greater London; In loco; GBP 70.000 - 95.000; Tempo pieno

Descrizione del lavoro

Ipsen Biopharm Ltd. is seeking a Regulatory Submission Project Manager to coordinate global regulatory submissions, ensure timeliness and compliance, and work with Regulatory Affairs, Clinical, Quality and Manufacturing teams across regions.

The role requires managing submission plans for new marketing authorisations and indications, applying project management principles, and driving continuous improvement in submission quality and efficiency.

Competenze

• Experience in the pharmaceutical industry with a focus on regulatory submission management and project oversight.
• Strong track record leading submission processes and CTD filings internationally.
• Solid understanding of drug development, strategy, and complex cross-functional programs.

Mansioni

• Plan, coordinate and deliver regulatory submissions to meet timelines and objectives.
• Lead global cross-functional submission teams and manage integrated timelines.
• Collaborate with Regulatory Affairs, Clinical, Quality and Manufacturing to ensure alignment and compliance.

Conoscenze

Pharma experience

Regulatory submissions

Project management

Cross-functional leadership

English fluency

Formazione

Degree in scientific discipline

Strumenti

eCTD publishing

RIMS

Regulatory tools

Descrizione del lavoro

Ipsen Biopharm Ltd. is seeking a Regulatory Submission Project Manager to coordinate global regulatory submissions, ensure timeliness and compliance, and work with Regulatory Affairs, Clinical, Quality and Manufacturing teams across regions.

The role requires managing submission plans for new marketing authorisations and indications, applying project management principles, and driving continuous improvement in submission quality and efficiency.