Are you energized by the challenge of shaping and accelerating the advances in application of precision medicine and digital health? If so, this Associate Director opportunity could be an exciting opportunity to consider.
As Associate Director/ Director - Global Regulatory Affairs, Precision Medicine & Digital Health you will manage/lead/be responsible to ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy 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
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Why you? Basic Qualifications:
- Accountable to GRL or Head of Regulatory Affairs, Precision Medicine & Digital Health, for development of appropriate 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, reviewing, contributing, and editing submission dossiers, and representing GSK with the regulatory agency.
- Work with the MDT to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified and the Medicine Profile. Lead interactions with local/regional /global regulatory authorities.
- Work within Oncology Global Regulatory Affairs capable of developing regulatory/validation strategies for the development and registration of companion diagnostics through laboratory-based tests or a commercial in vitro diagnostic test kit.
- Work directly with the Medicines Development Team (MDT), the Global Regulatory Lead and the Biomarker/Diagnostics Development Leader within Experimental Medicines Unit to assess the diagnostic test needs for the companion medication and determine the strategy for the development and delivery of the diagnostic test for use in the clinical development program and for the product post-approval.
- Experienced in determination of the regulatory options and the relative risk and benefits of various diagnostic test options and in thinking of innovative regulatory strategies for study risk determination, IDEs, PMA submissions
- Work with cross-disciplinary team to determine a transition “bridging” strategy for laboratory-based tests used during the clinical development program to an in vitro diagnostic or a laboratory-developed FDA approved test at the time of drug product approval.
- Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset.
- We are looking for professionals with these required skills to achieve our goals:
- Bachelor's required - (Master's or PhD Degree desired).
- 5 or more years' experience and demonstrated success in companion diagnostic or medical device regulatory affairs
- Experience of 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
- Extensive experience 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.
If you have the following characteristics, it would be a plus:
- Experience in line management
- Excellent negotiation skills across levels within an organization and with external stakeholders
- Ability to manage multiple projects and proactively plan
- Experience in working with strategic partners/cross company collaborations
- Experience in partnering with business development in due diligence efforts
- Prior Oncology Therapy Area experience preferred
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges 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 geneticsscience; 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, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas 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 culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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