Regulatory Affairs Senior Associate

Warren, NJ
February 12 2021
Organization Type
This Regulatory Affairs Senior Associate has responsibility for end-to-end regulatory activities for the assigned portfolio. Executes well-constructed and considered regulatory strategies that keep pace with the dynamic regulatory environment. Builds strong relationships with all stakeholders, internal and external.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Represent USRA on assigned projects, providing guidance on drug/device/food/cosmetic regulation and developing regulatory strategies. Includes review of formulas for local acceptability and claims development.
  • Collaborate with Global and US stakeholders (commercial, Global Reg, R&D etc) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and Probability of Success
  • Provide regulatory support to ex-US markets for brands where US is the Lead Market

  • Support end-to-end regulatory compliance of products in remit.
  • Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
  • Proactively identify potential regulatory risks and recommend solutions within defined scope of responsibility on the business.
  • Review labeling and formulations for acceptability.
  • Maintain high level of knowledge on the science of products within defined portfolio.

External Engagement:
  • Monitor regulatory trends that could impact portfolio.

Why you?

Basic Qualifications

  • Bachelor's Degree - Life science/Nutritional sciences/Pharmacy (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
  • Experience with the US OTC Monograph system and previous experience in oral health care
  • 2 + years' experience in a pharmaceutical or consumer health environment, direct US regulatory experience preferred

Preferred Qualifications

  • Master's degree (MBA, MS, MA), or PhD/PharmD/JD QP - Regulatory Affairs, Pharmacy
  • RAC Certification

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness


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