- Formulate, lead and drive CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
- 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 CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing risks and benefits.
- Identify as early as possible, the required documentation and any content, quality and/or time-lineissues. Negotiate the delivery of approved technical source documents in accordance with project time-line.
- Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
- Support or manage (with minimum supervision) interactions with FDA and other 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.
Does not supervise any direct reports.
The Scope of the Position: Formulate, lead and drive CMC regulatory strategy with minimum supervision for development and marketed products. Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission). Support or manage with minimum supervision FDA or other Health Authority interactions on CMC issues.
Key Relationships: Internal business functions relating to developing regulatory CMC strategies, CMC submission activities and health authority interactions on CMC issues.
- Knowledge of pharmaceutical industry regulatory affairs CMC discipline throughout the product life-cycle, with awareness of pre-clinical, clinical, commercialization, and operations.
- Knowledge of current and emerging issues and trends of the pharmaceutical regulatory environment.
- Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
- Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate in product development and post-approval activities.
- Ability to influence and partner with cross-functional teams.
- Ability to take innovative ideas from proof of concept to promote a successful product regulatory CMC submission and increase probability of regulatory approval.
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
- Self-motivated, detail-oriented and capable of working independently.
- Demonstrated ability in analytical reasoning and critical thinking skills.
- Strong business acumen and ability to see the business drivers outside of Regulatory Affairs.
- Excellent communication skills; both oral and written.
- Strong interpersonal skills with the ability to influence others in a positive and effective manner.
- Demonstrated ability to contribute to a continuous learning and process improvement environment.
- Capacity to react quickly and decisively in unexpected situations.
- 6+ years pharmaceutical industry and 3+ relevant regulatory CMC experience.
- Bachelor’s degree in science, bio-chemicalengineering, pharmacy or other health related field.
- Advanced degree highly preferred ( MS, Pharm. D., Ph.D. or equivalent)