Valeant Pharmaceuticals

Sr. Specialist, Regulatory Affairs-RX

US-NJ-Bridgewater
Job ID
5639
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 Affairs Senior Specialist executes on the pharmaceutical regulatory strategies for assigned brand products. Supports the Regulatory Affairs Senior Manager for Brand and Generic submission timelines and liaises with the country specific regulatory personnel for timely and accurate sharing of information to support compliance.

Responsibilities

Key activities/responsibilities

 

• Provide support for the execution of the pharmaceutical regulatory brand strategy for assigned products
• Support regulatory aspects of product development team for agency filing
• Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed in accordance with regulatory requirements; serves as designee as needed
• Support the preparation of documentation and materials required for meetings with Regulatory Authorities for assigned brand products
• Liaise with country-specific regulatory affairs personnel for international submissions and registrations
• Occasional travel may be required

 

 

Key relationships

 

• Demonstrated ability in analytical reasoning and critical thinking skills
• Strong capability to contribute to 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 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
• Knowledge of clinical development, including responsibilities for successful management of development milestones and market authorization
• Ability to partner within regulatory and with cross-functional teams in a pharmaceutical organization
• Ability to understand scientific information and assess whether technical arguments are articulated clearly
• Ability to assess project risks and where appropriate, escalate accordingly

 

 

Experience:

 

• 4+ years relevant pharmaceutical industry and regulatory experience (or 2+ years Pharmaceutical Brand Experience with a Masters in Regulatory Affairs)
• Brand experience preferred
• Bachelor’s degree in science or health related field
• Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)

 

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