Senior Director Regulatory Affairs CMC
Vor 5 Tagen
Blackfield Associates are supporting a renowned pharmaceutical client based in Switzerland, who have a requirement for a Senior Director, Regulatory Affairs CMC to join their team and lead from the front, both in strategy and team directive.
As Senior Director Regulatory Affairs CMC, you will:
- Manage regulatory submissions for assigned portfolio for global marketing applications and post approval life cycle management
- Oversight of a small Regulatory team, line management, and key stakeholders are apprised of developments that may impact regulatory success or risk
- Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance
- Evaluate change proposals for global regulatory impact and plan global variations and amendments
- Interact directly with international Health Authorities. Participate in and facilitate agency meetings.
To be considered for the role of Senior Director Regulatory Affairs CMC, you will have the following background and experience:
- Educated to BS or BA Degree in a related Scientific field, ideally an advanced degree holder
- More than 10 years experienced gained in Pharmaceutical regulatory affairs CMC, including product lead or senior CMC positions
- Experience with APIs, small molecules, drug products, biologics, analytical characterisation, process scale-up or asset registrations is required.
- Expect in Regulatory strategy and implantation
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support; application of knowledge to all areas of life-cycle management.
- Due to the nature of this role, previous people/ line management is a requirement - a confident communicator and hands-on attitude
- Expert in CTD authoring and/or review skills throughout the product lifecycle, with a solid understanding of global submission complexities.
This is a permeant position, with candidates engaging on a hybrid basis - weekly office presence is required.
Must hold valid right to work in Switzerland.
For enquires, please contact Rob Carnell at Blackfield Associates on or email.
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