GSK

Regulatory Senior Associate

Employer
GSK
Location
Warren, NJ
Salary
Competitive
Posted
October 29 2020
Ref
265671
Organization Type
Pharma
Are you interested in a regulatory affairs role that allows you to accelerate regulatory compliance across the business? If so, this Sr. Associate US Regulatory Affairs - Wellness could be an ideal opportunity to explore.

This position 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 supplement and food regulatory environment. Builds strong relationships with all stakeholders, internal and external.

Growth:
  • Represent USRA on assigned projects, providing guidance on dietary supplement regulation and executing regulatory strategies. Includes review of formulas for local acceptability and claims development. May also have some OTC Drug or Cosmetic products in portfolio.
  • Collaborate with Global and US stakeholders (commercial, Global Regulatory, R&D etc.) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and POS
  • Provide regulatory support to ex-US markets for brands where US is the Lead Market (as defined through SRA)


Stewardship:
  • 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:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's Degree in Life Science / Nutritional Sciences / Pharmacy
  • 2 + years experience in a pharmaceutical or consumer health environment, with dietary supplement or food experience required


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Masters (MBA, MS, MA), or PhD/Pharm


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.


*LI-GSK

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