Regulatory Project Manager

JR United Kingdom; United Kingdom; On-site; GBP 60,000 - 100,000; Full time

Job summary

A fast-growing biotech company is seeking a Regulatory Project Manager to lead submission efforts for innovative therapies targeting autoimmune diseases. In this pivotal role, you will manage global submission plans, ensuring compliance with regulatory timelines and overseeing the preparation of critical regulatory documents. This position offers the opportunity to work in a dynamic environment where your contributions directly impact the development of life-changing therapies. If you're passionate about advancing healthcare and have a strong background in regulatory affairs, this is the perfect opportunity for you.

Qualifications

• Experience in regulatory submission management for biologics.
• Strong project management skills with a focus on compliance.

Responsibilities

• Lead the submission team for regulatory documents.
• Oversee the preparation and submission of INDs, NDAs, and BLAs.

Skills

Regulatory Submission Management

Project Management

Pharmaceutical R&D

Biologics Development

Autoimmune Diseases Knowledge

Job description

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Regulatory Project Manager, United Kingdom

Client:

Planet Pharma

Location:

United Kingdom

Job Category:

Other

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EU work permit required:

Yes

Job Views:

16

Posted:

28.04.2025

Expiry Date:

12.06.2025

Job Description:

Our client is a fast-growing biotech company focused on immunology, specifically autoimmune diseases, and is looking for a Regulatory Project Manager to join their team.

The Regulatory Project Manager will lead the facilitation of the submission team, executing operational plans, and implementing project management techniques, processes, and tools. With a strong focus on submission management, you will oversee the preparation, compilation, and submission of regulatory documents (e.g., INDs, NDAs, BLAs, CTAs) across biologics and rare diseases at a global level.

Key Qualifications:

• Creating and maintaining global submission plans to ensure compliance with regulatory timelines
• Experience in Pharma R&D
• Experience in the development of biologicals and rare diseases