Director, Global Regulatory Affairs Lead- Oncology

Collegeville, Pennsylvania; Waltham, Massachusetts; Research Triangle Park, North Carolina
February 18 2021
Organization Type
Are you looking for a highly visible regulatory leadership role where you can lead Regulatory strategy for innovative and impactful Oncology assets? If so, this Director, Global Regulatory Affairs role could be an exciting opportunity to explore.

Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, 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 and Global Regulatory TA Head for development of appropriate regional 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 at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities. In performing the role, the job holder will be responsible for:

  • Ensuring the regulatory strategy that will deliver the needs of the local region(s),
  • taking in to account the needs of other regions globally
  • Implementation of the regional strategy(s) in support of the project globally
  • Lead regulatory interactions and the review processes in local region
  • Ensuring appropriate interaction with regional commercial teams in local region
  • Ensuring compliance with regional requirements at all stages of product life from C2MD
  • Showing the ability to advocate persuasively approaches to senior leaders in GSK and in Health Authorities
  • Ensuring capabilities of providing assessment of potential in license molecules

Why you?

Basic Qualifications:

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

  • Bachelor's degree in biological or healthcare science
  • Experience of all phases of the drug development process in
  • regulatory affairs, including for projects with little or no precedence.
  • Experience leading regional development, submission and approval
  • activities in local region(s).
  • Experience organising and executing milestone meetings and with relationship of one or more Health Authority
  • Experience of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally.
  • Experience in Oncology as a Therapeutic Area

Preferred Qualifications:

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

  • PhD or Masters' degree in life sciences or pharmacy
  • Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion. Commands attention and interest through use of appropriate communication techniques. Proven ability to foster strong matrix working.
  • Capable of facilitating groups of individuals to work together on creating solutions.
  • Ability to lead change and communicate difficult messages.
  • Ability to implement plans and hold self and team accountable for delivery of short and medium term goals.
  • Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome
  • Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context.
  • Proven ability to take sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints. In doing so, the job holder will use all available sources of information and weight benefits and risks before making important decisions. Shows a constant focus on improving performance and excellence in all tasks.
  • Challenges and questions ways of working to seek improved process.
  • Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets.

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:

  • 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.

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

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