Make your mark for patients
We are looking for a Global Regulatory CMC Lead to join us in our Regulatory Affairs team, based in either our Brussels (Belgium) or Slough (UK) offices.
About the role
The Global Regulatory Affairs CMC Lead is responsible for defining strategy, planning and preparation of regional specific CMC submission documentation on developed products, for assigned geographical regions and contributing to the preparation of global submission documentation to deliver timely approvals to meet business needs.
Responsible for authoring of the Module 3 components based on source document and Modules 2 for assigned developed products/projects, including new submissions and response to Questions from Health Authorities. He/she follows the process from creation, through review & approval and delivery of final documentation to the appropriate function.
Who you’ll work with
You will report into a Global Regulatory Affairs CMC Team Lead
What you’ll do
1. Responsible for developing and implementing the CMC & Devices regulatory strategy and submission plans for assigned developed projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
2. Responsible for leading complex projects and submissions, ensuring comprehensive regulatory CMC/Medical Device input is provided, and delivering results in a timely manner aligned with the regulatory strategy agreed upon with the Team Lead, Global Regulatory Affairs CMC & Devices Leadership, and Global Regulatory Lead.
3. Identifies supporting documents required for (global) submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
4. Ensures that the regional CMC/Medical Device regulatory strategy for the assigned projects/products are consistent with the Global Regulatory Affairs, supply and patient value goals and objectives and meets Health Authority requirements in assigned regions.
5. Responsible for writing regional and global CMC/Medical Device documentation for submissions as agreed with the Team Lead, in line with agreed global regulatory strategy, and within agreed timelines.
Interested? For this position you’ll need the following education, experience and skills:
6. Several years relevant experience in the pharmaceutical industry (manufacturing, analytical development, and quality assurance/control or related technical field) or a regulatory authority in a CMC/Medical Device review capacity, with experience in Regulatory Affairs CMC/
7. Proven track record of successful authoring and contribution to delivering CMC sections of post-approval submissions for biological and/or chemical entities
8. Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on post-approval products
9. Experience of direct communication and negotiation with regulatory agencies on CMC/Medical Device matters
10. Experience of participating in regulatory agency meetings on CMC/Medical Device matters
11. Demonstrated competence in leading/contributing on cross-functional teams and operating within a matrix organisational structure.
12. Experience and/or interest in digitalization, data management, and/or artificial intelligence
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!