GSK

Global Regulatory Manager - Wellness

Employer
GSK
Location
Warren, New Jersey; Richmond, Virginia
Salary
Competitive
Posted
October 23 2020
Ref
268732
Organization Type
Pharma
Job Type
Manager
Are you looking for a role where you can showcase your expertise in global regulatory affairs and dietary supplements? If so, this is the job for you.

As as Global Regulatory Manager - Wellness Professional you will be responsible to provide regulatory management, governance and expertise to a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of global collaborative relationships and ensure all regulatory requirements within the Category are met for both innovation and existing products, according to GSK Values. The role may require the individual to provide specialist regulatory advice across the Category and Function.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • Acts as a Business Partner and provides regulatory advice across a brand or subset of products covering dietary supplement or medicinal development and global regulatory requirements as appropriate.
  • Develops novel regulatory strategies and influences approaches within Project Teams in order to secure competitive approvals and speed to market in conjunction with Local/Region regulatory teams.
  • Communicates effectively within the function at all levels and within cross-functional Project Teams.
  • May supervise or mentor other team members.
  • Plans, prepares and delivers high-quality regulatory files to agreed timelines.
  • May lead non-product related activities within the function and input cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage.
  • May act as GSK representative to external groups on specific task forces within their field of expertise.
  • Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated.
  • In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including maintenance activities, Design to Value, complexity reduction, value engineering initiatives, change controls, etc. with supply chain and technical excellence.
  • Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering, Nutrition)
  • 5+ years experience in Regulatory Affairs
  • 3+ years dietary supplement experience in Regulatory Affairs


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Masters Degree (MBA, MS, MA), or PhD/PharmD/JD QP
  • RAC


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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