GSK

Sr. Associate - US Regulatory Affairs

Employer
GSK
Location
Warren, NJ
Salary
Competitive
Posted
November 19 2020
Ref
271371
Organization Type
Pharma
Are you looking for a role in which you will be responsible for end-to-end regulatory activities for the assigned portfolio?

As a Sr. Associate in Regulatory Affairs, you will execute well-constructed and considered regulatory strategies that keep pace with the dynamic FDA submissions and OTC Monograph regulatory environment including novel innovation areas in self-care. This role will support the US portfolio, including in Oral Health and Skin Health products.

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

Growth:

  • Recommend and execute regulatory strategies for the portfolio, proactively seeking innovative and rapid path to market.
  • Represent USRA on assigned projects, providing guidance on FDA regulations and developing regulatory strategies and required submissions. Includes review of formulas and technologies 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 POS.
  • Deliver regulatory support to ex-US markets for brands where US is the Lead Market (as defined through SRA).
  • Participate in interactions with regulatory authorities in order to seek guidance, expedite approval of pending applications


Stewardship:

  • Accountable for ongoing 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, formulations and technologies for acceptability.
  • Maintain high level of knowledge on the science of products within defined portfolio and emerging areas of self-care technologies.


External Engagement:

  • Monitor regulatory trends that could impact portfolio.
  • Participate in advocacy activities to help shape new self-care applications and regulatory reforms.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in Life science/Pharmacy/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering).
  • Minimum of 2 +years experiencein a pharmaceutical or consumer health environment


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Highly skilled in scientific interpretation/ evaluation/ communication of technical information.
  • RAC, RD, Master's degree or Doctorate
  • Specialized in Regulatory Affairs, Pharmacy, Medical Devices
  • Practically-applied demonstration of intellect and an ability to interface effectively with internal and external stakeholders (other commercial and technical staff, local senior management, external regulators, trade associations)
  • Experience in Regulatory Affairs, medical technology environment including diagnostics and digital health is a plus.


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

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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