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Senior Director, Global Regulatory Affairs Oncology

Employer
GSK
Location
Rockville, Maryland; Hartford, Connecticut; Dover , Delaware; Waltham, Massachusetts; Trenton, New Jersey
Salary
Competitive
Closing date
Jul 14, 2022

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We have exciting career opportunities in Global Regulatory Affairs for senior director level individual strategic contributors to support exciting and innovative research across the Oncology therapies. We have been actively exploring ways to help, with our science and expertise, alongside protecting the health and wellbeing of our people and managing our global supply chains to support patients and consumers who depend on our products.

This represents an exciting opportunity to be part of GSK Pharma R&D, who is committed to innovative scientific research and discovery to help people do more, feel better, live longer.

Ideally, the role will be located on East Coast, but remote working arrangements may be considered for appropriate US candidates.

Job purpose:

Ensure the development of appropriate global and/or regional regulatory strategy(ies) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicine Profile.

This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data. Position may have direct reports.

General information :
  • Primary locations: US i.e. GSK East Coast sites (you will mainly work on EST time)
  • Asset/product: Oncology/Cell Therapy
  • Role reports to: Anne, Senior Director and Team Leader, Global Regulatory Affairs
  • Direct reports / people management : no


Key responsibilities:

Accountable to GRL (if regional role) and/or Global Regulatory TA Head for development of appropriate regional or global regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with regulatory agency (ies). Work with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile. Work closely with the global commercial team and local regulatory team to secure best possible labelling commensurate with the available data Lead interactions with local / regional /global regulatory authorities. In performing the role, the job holder will be responsible for:
  • To proactively develop a regulatory strategy that will deliver global and/or regional needs with initial focus on the key markets identified. In doing so, will promote innovative regulatory approaches when they benefit advancement of a given program. Implementation of the global and/or regional strategy(s) in support of the project
  • Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset.
  • Lead regulatory interactions and the regulatory review processes in global/local region
  • Ensuring appropriate interaction with global/regional regulatory counterparts and global commercial teams
  • Ensuring compliance with global/regional requirements at all stages of product life
  • Able to advocate persuasively to senior leaders in GSK and in Health Authorities
  • Work alongside other core members of the MDT and/or EDT providing broad development input/expertise to their programs (over and above regulatory input).
  • Able to effectively lead the Regulatory Matrix Team
  • Capable of providing critical regulatory assessment as part of due diligence / business development activities


Why you?

Basic Qualifications:

We are looking for professionals with the following required skills to achieve our goals (must-have):
  • Bachelor degree in Biological or Healthcare Science
  • Experience in RA and Oncology
  • Experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence
  • Experience in leading global/regional development, submission and approval activities in global/local region(s) including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority
  • Knowledge of clinical trial and licensing requirements in all key markets in the region and sound knowledge globally. Ideally, proven experience of leading regulatory activities outside local region.
  • Knowledge of Oncology and track record in product development


Preferred Qualifications:

The following characteristics are assets (nice-to-have):
  • Master's degree or PhD in Biological or Healthcare Science
  • Experience with RA filings


Ability to:
  • Set direction and inspire
  • Communicate, impact, influence and negotiate
  • Think strategically


Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, technology and talent to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing . So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

*LI-GSK

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