Senior Regulatory Affairs Specialist

Date: Feb 11, 2024

Location: US-NJ-Bridgewater, New Jersey, US

Company: Bausch + Lomb

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. 


Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. 

 

Objectives/Purpose of Job:

  • The Regulatory Affairs Senior Specialist handles US regulatory development aspects for Over-the-Counter (OTC) or cosmetic products, as assigned.
  • Provides Regulatory guidance to support marketed OTC monograph/NDA or cosmetic products.
  • Manages relevant regulatory strategy components and interactions with FDA, as needed, for assigned products.

 

Key Activities/Responsibilities:

  • Provide support for the execution of the pharmaceutical regulatory strategy for assigned products.
  • Support regulatory aspects of product development team for agency filing.
  • Work with the Pharmaceutical Regulatory Management 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 products.
  • Liaise with country-specific regulatory affairs personnel for international submissions and registrations.
  • Occasional travel may be required.
  • Other job responsibilities as needed.
  • Excellent communication / interpersonal and writing skills.
  • Self-motivated, detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies and capable of working independently.
  • Computer literate/capable of using IT systems with technology skills (e.g., MS Office Applications, Adobe Acrobat, MS Project).
  • Knowledge of country regulations (pharma), post market activities.
  • Ability to work and contribute to a team environment.
  • Demonstrated ability in analytical reasoning and critical thinking skills.
  • Demonstrated good documentation practices and requirements for managing regulated records.
  • Demonstrated ability to contribute to a continuous learning and process improvement environment.

 

Qualifications/Training:

  • 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 regulations 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:

  • 3+ years relevant pharmaceutical industry and regulatory experience (or 2+ years Pharmaceutical Brand Experience with a Masters in Regulatory Affairs).
  • Pharmaceutical (Brand, Generic and Consumer) experience preferred.
  • Bachelor’s degree in science or health related field.

 

 

This position may be available in the following location(s): US - Bridgewater, NJ

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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 Bausch+Lomb's Job Offer Fraud Statement.

 

Our Benefit Programs: https://www.bausch.com/careers/benefits/

 

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.