The Regulatory Affairs – CMC Associate Director independently manages all regulatory CMC aspects of Valeant’s Pharmaceuticals products throughout their lifecycle. This includes Brand, Generics, OTC/Nutritionals, Dietary Supplements and Medical Devices. The Associate Director is responsible for the regulatory CMC strategies of all submissions for products under his/her responsibility as well as managing interactions with regulatory authorities on CMC issues.
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 timeline issues. 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 FDA 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.
Knowledge of pharmaceutical industry regulatory affairs CMC discipline throughout the product lifecycle, with awareness of preclinical, 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 influence external regulatory stakeholders and shape the external regulatory environment.
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.