Regulatory Affairs Manager

Employer
GSK
Location
Warren, NJ, New Jersey
Salary
Competitive
Posted
Apr 19, 2021
Closes
Apr 29, 2021
Ref
543879
Jobseeker Type
Professional
Organization Type
Corporate
The Regulatory Affairs Manager position brings strategic regulatory leadership toassignedproducts and projects.Trusted advisor to cross-functional partners, leads team to deliver well-constructed and considered regulatory strategies that meet consumer and business needs. Builds strong relationships with all stakeholders, internal and external.

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

Growth:
  • Recommendand executeregulatory strategies for the portfolio,proactively seeking innovative and rapid path to market. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the regulatory environment
  • Key advisor on the applicable regulations that govern products in remit, providing guidance and considering all possible interpretations and regulatory pathways
  • Strong understandingof regulations that cover assigned portfolio (US Monograph, NDA, Devices, DSHEA, etc.)
  • 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 andPOS
  • Deliver Regulatory support and guidance to ex-US markets for brands where US is the Lead Market (as defined through SRA)
  • Participate in interactions (meetings, teleconferences) with regulatory authoritiesin order toseek guidance, expedite approval of pending applications


Stewardship:
  • Accountable for the 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 manage impact of regulatory changes within defined scope of responsibility on the business
  • Maintain high level of knowledge on the science of products within defined portfolio


External Engagement:
  • Key internal advisor on existing and emerging trends for products/categories in remit. Anticipate threats and opportunities.Interpret regulatory actions and provide the business and R&D with robust analyses and recommendations for action.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's Degree in Life science/Pharmaceutically-relatedscience (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
  • 5 +years' experience in Regulatory Affairs
  • 2 + years' experiencein Consumer Health


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Master's or PhD Degree in Life science/Pharmaceutically-relatedscience (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)


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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