Make your mark for patients
We are looking for a Regulatory CMC Scientist to join us in our Global Regulatory team, based in any of our Brussels (Belgium) or Slough (UK) offices.
About the role
Define the strategy, planning and preparation (writing and review) of CMC submission documentation for regulatory submissions, for marketed Biological products, from a global/regional perspective to achieve timely approvals to meet business needs.
Who you’ll work with
You will work within the Regulatory CMC team and partner with other technical functions across the business.
What you’ll do
1. Responsible for authoring regional and global CMC documentation for submissions in line with agreed global regulatory strategy, and within agreed timelines.
2. Provide regulatory CMC leadership on the cross functional sub teams (Global Regulatory Affairs (GRA) Teams and Technical Teams and advise on best practices
3. Contribute and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regions
4. Ensures effective communication of CMC regulatory strategy, risks, and overall plan to GRA Teams, Technical, Development and Commercial Teams
5. Highlights anticipated and ongoing critical issues arising through the product life cycle in a timely manner to senior management to enable communication to key stakeholders
6. Lead or contribute to ongoing process improvement and department initiatives within the CMC Regulatory Affairs function, including process improvements, SOP review and development, and evaluation/implementation of digital strategies and tools.
Interested? For this position you’ll need the following education, experience and skills:
7. Bachelor’s degree, Master’s preferred in a relevant life science or business-related discipline
8. Significant relevant experience in the pharmaceutical industry preferably in Regulatory Affairs CMC for Biologics and/or in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field, or as a regulatory authority in a CMC review capacity
9. Proven track record of successful authoring and contribution to delivering CMC sections of IMPD/ MAA/ variations for biological products
10. Knowledge of GMP requirements, standard systems (e.g. change management systems and tools)
11. Effective interpersonal, presentation and communication skills with established internal and external stakeholders
12. Proven leadership, problem-solving ability, flexibility, influence, and effective teamwork skills.
13. Demonstrated ability to use AI tools in daily professional work
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!