Regulatory Affairs Manager:
CMC Expertise Sought
We are seeking a seasoned Regulatory Affairs expert to join our team. As a CMC Manager, you will provide strategic and operational global direction for the development and post-approval activities of our products.
About the Role:
* You will formulate and lead global CMC regulatory strategy, balancing business benefit with regulatory compliance.
* Lead and implement global CMC submission activities, including planning, authoring, reviewing, coordination, and submission.
* Identify required documentation and negotiate delivery of approved technical source documents in accordance with project timelines.
* Autor high-quality CMC documentation for Health Authority submission, applying agreed CMC global regulatory strategies, current trends, and guidelines.
* Proactively communicate CMC regulatory strategies, risks, and key issues throughout the product life cycle.
Key Requirements:
* Education:
Science degree (e.G., Chemistry, Pharmacy, Biochemistry) or equivalent;
advanced degree desired.
* At least 2 years' experience in regulatory CMC or pharmaceutical industry experience;
working knowledge in regulatory submissions desirable.
* Demonstrated working knowledge of chemistry/biotechnology, analytics, or pharmaceutical technology.
Benefits and Rewards:
We offer an attractive incentive program, modern company pension scheme, childcare facilities, learning and development opportunities, and worldwide career possibilities within the organization.