- Formulate, lead and drive post-approval CMC regulatory strategy for marketed products with input from Product Lead as needed.
- Provide input into CMC regulatory strategy for development products working closely with the Product Lead.
- Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs, R&D, TechOps and Supply Chain as appropriate in an a timely manner.
- Lead and drive all post-approval CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing regulatory compliance risks and business benefits.
- Identify as early as possible, the required documentation and any content, quality and/or timeline for post-approval submissions. Negotiate the delivery of approved technical source documents in accordance with project timeline.
- Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
- Manage interactions with Health Authorities on CMC issues.
- Provide regulatory support to other Valeant functions during Regulatory Authority inspections.
- Serve as Regulatory Affairs representative on facility/site Local Change Management Boards.
- Participate in assigned due diligent business activities.
- Review and provide input on proposed health authority guidance documents on CMC issues.
Scope of Position:
Formulate, lead and drive post-approval CMC regulatory strategy for marketed products. Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission). Lead FDA or other Health Authority interactions on CMC issues.