Summary
The Manager, Regulatory Affairs Global CMC will be responsible for CMC regulatory support of commercial/development projects worldwide.
Essential Functions
- Ensure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments. Coordinate with other team members to manage regulatory assessments for changes for commercial products.
- Manage GRA CMC document lifecycles in electronic documentation system, including maintenance of document content, format(s) and metadata.
- Maintenance of current regulatory product information to support product release for assigned commercial products –including the management and maintenance of GRA CMC information (as per IDMP) within electronic regulatory information management system.
- Coordinating planning, writing and reviewing CMC information for all regulatory compliance submissions and notifications (Annual Reports, Renewals, Notifications and YPBRs) for assigned commercial products.
- Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies (through application of professional/technical expertise and team procedures) for commercial products under the supervision of GRA-CMC leadership.
- Through the performance of risk assessments, work with GRA-CMC leadership to identify and communicate potential risks associated with strategy scenarios to the multi-disciplinary team(s).
- Support EU, US and global commercial license maintenance.
- Coordinate the preparation of documents and publishing requests to support responses to regulatory agencies, under the supervision of GRA-CMC Leadership. Manage timelines to ensure approvals are timely and development objectives are met.
- Effectively communicate with multiple cross functional teams in support of Regulatory CMC at internal meetings for assigned commercial products.
- Verify electronic publishing of regulatory submissions.
- Support GRA-CMC team projects in the authoring of Module 3 CTD documents including health authority responses, as required.
- Support continuous improvement opportunities for the GRA-CMC and the broader GRA team.
- Ensure compliance with company policies, procedures and training expectations.
- Support the writing and implementation of new procedures and processes in GRA team.
Required Knowledge, Skills, and Abilities
- Solid understanding of quality management systems including change controls, documentation management systems and experience with electronic Common Technical Document eCTD submissions.
- Previous experience with regulatory information management systems would also be of advantage.
- Solid working knowledge of CMC regulatory and ability to generate clear, well-argued positions.
- Must have experience with CMC regulatory documents (variations, supplements etc.).
- Knowledge of FDA, EMA and ICH guidelines.
- Exceptional interpersonal and communication skills with the ability to work individually, within a multi- disciplinary team, as well as with external partners and regulators.
Required/Preferred Education and Licenses
- Educated to BSc/BA level
- Previous regulatory CMC experience
- English language, written and verbal communication skills
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