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Bausch + Lomb is a leading global eye health company seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our global technical CMC team, you will be responsible for developing and implementing global regulatory CMC strategies for submissions and content of CMC dossiers for prescription drugs and consumer products.
Key Responsibilities- Proactively communicate CMC regulatory strategy, key issues, and critical topics throughout the life cycle to interdisciplinary project teams and management.
- Lead and drive all CMC submission activities, including planning, authoring, reviewing, coordination, and submission, for assigned projects/products.
- Identify required documentation and content, quality, and timeline issues.
- Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
- Provide regulatory support to other company functions during Regulatory Authority inspections.
- Serve as Regulatory Affairs representative on facility/site Local Change Management Boards.
- Review and provide input on proposed health authority guidance documents on CMC issues.
- Author annual reports for non-marketed Rx products independently.
- Provide the CMC portion of Annual Product Reviews (APRs) for a specified internal manufacturing site.
- Author minor CMC supplements with supervision.
- Work closely with CMC Managers and Product Leads on international market requests.
- Act as primary contact with regulatory authorities with limited supervision.
- Bachelor's degree or equivalent.
- Minimum of 3 years Regulatory Affairs experience or relevant experience in a regulated environment.
- Excellent communication, interpersonal, and writing skills.
- Self-motivated and capable of working independently with minimal supervision.
- Skilled in basic technologies, such as MS Office Applications, Adobe Acrobat, and MS Project.
- Knowledge of country regulations, post-market surveillance, ISO, and IEC.
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
- Command of the English language (verbal and written).
- Ability to understand scientific information and assess whether technical arguments are articulated clearly.
- Experienced in good documentation practices and requirements for managing regulated records.
- Demonstrated ability to contribute to a continuous learning and process improvement environment.
- Some knowledge of creating a successful product regulatory strategy.
- Operates with a sense of urgency, agility, and flexibility.
