Global Regulatory Affairs CMC Lead

작업 내용

To strengthen our Global Regulatory Affairs function, based in either of our UK or Belgium affiliates we are looking for a talented individual to fill the position of Global Regulatory Affairs CMC Lead.

As a Global Regulatory Affairs CMC Lead you will:

• Cover global submissions for all phases of the product lifecycle (phase 1-3, MAA/BLA/NDA submission and post approval) for new biological entities.
• Be responsible for the line management of the team members reporting into her/him. The Lead assigns projects to the team members and supports the team members in setting regulatory CMC/Medical Device strategies and their daily work.
• Accountability for the team members defining strategy, planning and the preparation of CMC documentation and sections/Medical Device documentation for regulatory submissions from a global perspective to achieve timely approvals to meet business needs.
• Provide coaching as needed and ensures the talents of the team members are enhanced through the assigned projects and through development opportunities.
• Define regulatory strategy for all submissions being prepared within the Center of Expertise under their responsibility. The Lead is also responsible for appropriate planning of resources from a global perspective to achieve timely approvals to meet PVU business needs.
• Responsible for leading or providing input to internal regulatory business initiatives (e.g. as process owner for QMS@GRA initiatives) and cross functional work streams as assigned.
• For assigned products/projects the Lead provides regulatory CMC/Medical Device leadership on the cross functional sub teams (GRA Teams and Supply & Technology Solution (S&TS) Teams) and advises on best practices and/or supports Patient Solution Missions Team (PSMT), as assigned by the GRA Leadership Team (GRA-LT and GRA-CMC & Devices-LT).
• For assigned products, the Lead is responsible for leading and ensuring adequate provision of regulatory CMC/Medical Device input, to all Health Authority (HA) interactions and/or Notified Bodies (NBs) on CMC and/or Medical Device matters in all regions, as agreed with the GRA Leadership Team and the PVU-GRL.

Interested? For this position you’ll need the following education, experience and skills:

• Bachelor’s degree
• Significant experience in the pharmaceutical or Medical Device industry or a regulatory authority in a CMC review capacity
• Proven track record of successful leadership in delivering CMC sections of new marketing authorisations, clinical trial applications and post-approval submissions for biological or chemical entities
• Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
• Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
• Extensive experience of direct communication and negotiation with regulatory agencies on CMC/Medical Device matters
• Extensive experience of participating in regulatory agency meetings on CMC/Medical Device matters
• Demonstrated competence in leading cross-functional teams and operating within a matrix organisational structure

Why you should apply

At UCB, we welcome passionate individuals who thrive on change and are ready make their mark for patients. Working for us, you will discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact while putting continuous efforts into cultivating a workplace culture where everyone feels included, respected and has equitable opportunities. Through meaningful recognition and a motivating atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe that you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.