Regulatory Affairs Manager
1 month ago
We are seeking a highly experienced Regulatory Affairs Manager to lead our global biosimilar regulatory strategy and ensure compliance with regulatory requirements.
The successful candidate will have a strong background in drug substance manufacturing, process characterization, and regulatory strategy development.
- Develop and execute global regulatory strategies for biosimilar products
- Ensure compliance with regulatory requirements and approved filing plans
- Collaborate with cross-functional teams to support product development and registration
- Provide regulatory direction on global regulatory requirements
- Lead regulatory compliance for biosimilar products
Key Responsibilities:
- Develop and execute global regulatory strategies for biosimilar products
- Ensure compliance with regulatory requirements and approved filing plans
- Collaborate with cross-functional teams to support product development and registration
- Provide regulatory direction on global regulatory requirements
- Lead regulatory compliance for biosimilar products
Requirements:
- Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) and process comparability for biologics (monoclonal antibodies/growth factors/hormones)
- Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products
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