Valeant Pharmaceuticals

Associate Director Regulatory Affairs CMC

US-NJ-Bridgewater
Job ID
8585
Pos. Category
R&D
Pos. Type
Full Time

Overview

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.

 

Responsibilities

 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.

Qualifications

 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.

 

  • 10+ years pharmaceutical industry and 8+ relevant regulatory CMC experience.
  • Bachelor’s degree in science, bio-chemical engineering, pharmacy or other health related field.
  • Advanced degree highly preferred ( MS, Pharm.D, Ph.D. or equivalent)

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