Valeant Pharmaceuticals

Senior Manager, Regulatory Affairs

US-NJ-Bridgewater
Job ID
9550
Pos. Category
R&D
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

The Regulatory Senior Manager Handles all regulatory development aspects for prescription brand (“Brand”) products. Participates on the product development team to provide regulatory guidance for Pharmaceutical Brand products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for Brand products. May perform due diligence efforts on new product opportunities.

Responsibilities

  • Responsible for developing a product regulatory strategy for Brand pharmaceutical products
  • Liaise with regulatory counterparts to ensure regional requirements are incorporated into product strategy development
  • Develop a product regulatory timeline aligned to the business unit’s product development, with key regulatory milestone, and activities for agency filing
  • Coordinate with RA- Labeling on the development of product labels
  • Ensure labeling content and product documentation is developed in accordance with regulatory requirements
  • Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
  • Coordinate with RA Operations to ensure timely and accurate submissions to Regulatory  Authorities
  • Act as a the primary regulatory contact with Regulatory Authorities for assigned pharmaceutical Brand products
  • Liaise with specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations
  • Manage interactions with other functions (e.g., Quality, Compliance) during Regulatory Authority inspections
  • Provide regulatory guidance/input to internal product review boards
  • May manage assigned personnel
  • Occasional travel may be required

Key Relationships: 

  • Demonstrated ability in analytical reasoning and critical thinking skills
  • Strong capability to contribute and lead a team environment
  • 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
  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
  • Focused ability to influence operational excellence and performance metrics
  • Risk adverse where needed with the ability to identify potential solutions to complex problems

Qualifications

  • Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
  • Knowledge of domestic and international laws, regulations, and guidance that affect Brand products
  • Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
  • Demonstrated experience with health authority submissions, i.e, authored, reviewed and managed an original/supplemental application (IND, NDA, BLA, MAA, CTA, NDS, etc.
  • Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for Brand products
  • Ability to influence and partner with cross-functional teams in a pharmaceutical organization
  • Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy 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
  • 8+ years relevant pharmaceutical industry and regulatory experience
  • Pharmaceutical brand experience highly preferred
  • Bachelor’s degree in science or health related field
  • Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

 

 

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