Job Summary
We are seeking an experienced CMD Regulatory Affairs Senior Manager to join our team. This role will be responsible for developing and implementing CMC strategies for drug product development and manufacturing of injectable biologics.
The ideal candidate will have a strong background in pharmaceutical sciences, with expertise in regulatory affairs and experience working with global regulatory agencies.
Key Responsibilities
* Develop and implement CMC strategies for drug product development and manufacturing of injectable biologics
* Lead US (BLA) and EU (MAA) CMC strategy and authoring for drug development through to commercialization worldwide
* Engage with regulatory agencies and commercial partners to ensure compliance with regulations and standards
* Collaborate with cross-functional teams to develop and implement effective CMC strategies
About Our Company
Our company has over 10 years of experience in Biologics, focusing on producing therapies using antibodies. We strive to offer the best antibody-based medicine to patients globally.
Requirements
* Experience in CMC specialist in Drug Product development and manufacturing of injectable biologics
* Strong background in pharmaceutical sciences
* Expertise in regulatory affairs
* Experience working with global regulatory agencies
* Ability to collaborate with cross-functional teams