GSK

Regulatory Affairs Manager

Employer
GSK
Location
Warren, NJ
Salary
Competitive
Posted
January 07 2021
Ref
275309
Organization Type
Pharma
Job Type
Manager
Growth:
• Recommend and execute regulatory 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 understanding of 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 and POS
• 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 authorities in order to seek guidance, expedite approval of pending applications.
• Develop direct reports to have strong regulatory capabilities
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

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree BA or BSc in Life science/Pharmaceutically-related science: Chemistry, Pharmacy, Biochemistry, Biology, or Medical Engineering
  • 5 years' experience in Regulatory Affairs
  • 2 years experience in Consumer Health


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QPin Regulatory Affairs and Pharmacy
  • Excellent communication skills at all levels
  • Experience with regulatory audits


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.


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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