Executive Director and Head Established Products Therapeutic Group
Sector: Science and Pharmaceutical, Technology
Role: Executive
Contract Type: Permanent
Hours: Full Time
Site Name: USA - Pennsylvania - Upper Providence, Belgium-Rixensart, GSK HQ, USA - Massachusetts - Waltham, Zug House
Posted Date: Dec
Job Purpose
The Executive Director is accountable to the SVP, Regulatory Affairs Therapeutic Group, for influencing and driving the overall direction and strategy for the Established Products (EP) Therapeutic Group via the development and implementation of innovative regulatory strategies to optimize the life cycle management including divestment opportunities. The role will require extensive matrix working within GSK to SVP level and representing GSK with regulatory agencies as appropriate. This role will oversee the budget, staffing and operations.
The Executive Director has full accountability for overseeing regulatory support for the EP portfolio, including the associated communication strategy to all regulatory authorities. The Executive Director is directly accountable for regulatory filings (excluding CMC and labelling), interactions globally and works with those outside of GRA (e.g. LOC, commercial and manufacturing) to facilitate other international filings. The Executive Director ensures that sound regulatory practices are fully integrated into regulatory work, that all regulatory obligations are met and that all documents submitted to regulatory agencies are appropriately reviewed to ensure they are complete, scientifically and technically accurate, of high quality, regulatory compliant and presented in a manner that facilitates agency review. The incumbent works across the GRA matrix with the relevant functional areas to ensure connectivity and alignment of activities for labelling and CMC.
Key Responsibilities
- Leads directly and indirectly all regulatory activity in support of assigned EP product portfolio, working across the regulatory matrix to ensure alignment with business strategies.
- Contributes to the creation and implementation of product life cycle plans that incorporate regulatory strategies designed to maximize the likelihood of successful regulatory applications.
- Represents the global regulatory function as the business partner to the General Medicine commercial leadership team and General Medicine PALT ensuring regulatory insights are incorporated into business strategies, regulatory risks are managed and obligations met.
- Provides leadership to Portfolio Optimisation regulatory activities including market expansion and divestment/discontinuation in support of business goals including representation on senior boards including Portfolio Optimisation Board.
- Provides leadership of function assessing and responding to changing business unit strategy; define and build regulatory capabilities to support.
- Exhibits leadership in the formulation and execution of global regulatory strategies and assist in the development of and implementation of policies and strategies that optimize product stewardship.
- Monitors and anticipates regulatory, scientific and pertinent legal issues related to the regional portfolio and assess potential impact on the Company, to advise management on events of significance to the Company's business interests; influences changes in guidelines and regulations to strengthen the regulatory review process and ensures core operations are proactively aligned with emerging policies.
- Acts as a credible, influential, respected spokesperson with external agencies and third parties, ensuring appropriate, proactive communication and assuring collaborative approaches to agency and third party interactions. Works with other stakeholders to proactively shape the external environment in a manner consistent with GSK principles and priorities.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree
- 10+ years' experience in Regulatory Affairs
- Previous management line-management experience
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- PhD
- Extensive knowledge of relevant therapeutic area or proven track record of being able to develop product / therapeutic knowledge in new area
- Proven experience of leading development, submission and approval activities including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority
- Extensive knowledge of clinical trial, licensing, supply chain and life cycle management requirements in priority markets and sound knowledge globally. Ideally, proven experience of leading regulatory activities globally
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (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.
