Senior Director, Regulatory Affairs, Precision Medicine Digital Health

Job Location	Pennsylvania, Exeter
Education	Not Mentioned
Salary	Competitive salary
Industry	Not Mentioned
Functional Area	Not Mentioned
Job Type	Permanent, full-time

Job Description

Site Name: Home Worker - GBR, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence, USA - North Carolina - Research Triangle ParkPosted Date: Jul 27 2020As Senior Director, GSK Global Regulatory Affairs you will provide critical strategic and operational regulatory leadership across the Oncology portfolio of products that require the co-development and registration of a diagnostic. You will also provide medical device, digital health regulatory strategic support in the area of use of real-world data as applicable to regulatory strategy and serve as a resource for the evaluation of stand-alone medical and digital devices and in vitro diagnostic tests of interest to GSK. Prior experience in laboratory testing or diagnostics or regulation thereof is highly preferred.In this role you will 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:

Accountable to GRL as part of the Regulatory Matrix Team, you will report to Head, Regulatory Affairs, Precision Medicine & Digital Health, responsible 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 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.

Contribute to Diagnostic Regulatory policy initiatives working with Regulatory Policy group and participate in meetings with trade associations, patient advocacy groups and health authorities.

Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset.

Work alongside other core members of the MDT and/or EDT providing broad development input/expertise to their programs (over and above regulatory input).

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

Masters Degree.

10 or more years’ experience and demonstrated success in companion diagnostic or medical device regulatory affairs

Proven 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 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.

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

PhD (or equivalent)

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

Why GSK Our values and expectations are 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:

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

Managing individual and team performance.

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

Implementing change initiatives and leading change.

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

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

Developing people and building a talent pipeline.

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

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

Budgeting and forecasting, commercial and financial acumen.

*LI-GSKIf you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or + (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action

APPLY NOW