Regulatory Compliance Manager

Description

Regulatory Compliance Manager



Currently we are supporting a Biotechnology organisation, which is looking for a Regulatory Compliance Manager. With a focus on CMC dossiers, you will be ensuring regulatory compliance for new and existing biotech products with international regulations and corporate procedures. You will report to the Head of Quality and Regulatory Affairs in the Pharma Biotech Industrial Affairs team and will be a key link between the manufacturing Sites’ Regulatory Affairs Units, Biotech team and global regulatory affairs.



Responsibilities:



- Provides regulatory support for the Drug Substance Biotech manufacturing sites within the division.

- Defines and supports the implementation of the regulatory compliance process ensuring consistency within the company and regulatory requirements.

- Defines and supports the implementation of change control process where required, i.e. coordinates and leads the Change Control Committees (CCC) and ensures follow-up.

- Ensures implementation of corporate procedures, systems and tools for all regulatory activities done by the Site Regulatory Affairs Unit.



Requirements: 



- Strong knowledge of worldwide pharma regulatory affairs expectations.

- Strong experience with Biotechnology products, GxP and CMC dossier submission ideally for both new and existing products.

- Good comprehension of quality requirements for biotech products desired.

- Excellent understanding of the English Language (written and verbal).

- Strong communicator and excellent relationship building skills.