CMC, Regulatory Affairs Manager/Associate Director

Collegeville, Pennsylvania; Waltham, Massachusetts
December 15 2020
Organization Type
Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore.

As a Regulatory Affairs Management Manager, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US.

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

o Ensure cross portfolio aligned regulatory strategy to assure timely approvals for all US submissions.

o Facilitate integration of US-based individuals within portfolio group and integration of US-specific regulatory aspects into projects in general within the portfolio.

o Managerial responsibilities for US-based individuals within a specific Global Regulatory Affairs (GRA) project/portfolio, advice for US specific activities/processes, ensure appropriate training of US-based staff, and issue escalation.

o Ensure quality and process improvement within US and provide cross portfolio resources support as appropriate.

o Provide advice on US-specific activities and ways of working, processes as mentor or coach; in this role, provide support, as needed, for meetings/teleconferences with US regulatory agency.

o Ensure the training of US-based personnel, and ensure completeness of training curriculum, in compliance with Corporate Integrity Agreement (CIA).

o Ensure that regional strategic input is provided into Regulatory Affairs project strategy and escalation as appropriate.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

o Bachelor's Degree in Science or related field .

o More than 8 years of experience in regulatory affairs.

o More than 2 years e xperience in managing teams and leading in a matrix organization.

o Five years e xperience with US and EU regulatory environment.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

o Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline.

o Experience at a large global pharmaceutical or vaccines company

o Experience leading global teams

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:

o Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk

o Managing individual and team performance.

o Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

o Implementing change initiatives and leading change.

o Sustaining energy and well-being, building resilience in teams.

o Continuously looking for opportunities to learn, build skills and share learning both internally and externally.

o Developing people and building a talent pipeline.

o Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.

o Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.

o Budgeting and forecasting, commercial and financial acumen.

*This is a job description to aide in the job posting, but does not include all job evaluation details.


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