Senior Director, Team Leader - Global Oncology Regulatory Affairs
- Zug, Switzerland
GlaxoSmithKline (GSK) Pharmaceutical Research & Development (R&D is committed to innovative scientific research and discovery to help people do more, feel better, live longer. The Oncology Global Regulatory Affairs (GRA) Therapeutic Group (part of the Global Regulatory and Quality organisation in Pharmaceutical R&D) develops global regulatory strategies to deliver the innovative oncology portfolio.
We have a fantastic opportunity for a talented Global Regulatory Affairs Senior Director with extensive regulatory affairs knowledge/experience to join our Therapeutic Group in Zug, Switzerland. Reporting into the VP for Regulatory Affairs, this represents an exciting opportunity to become a focal part of GlaxoSmithKline (GSK) Pharmaceutical Research & Development (R&D), which is committed to innovative scientific research and discovery.
In this role, as a member of the Global Oncology RA Leadership team, you will provide regulatory strategic leadership and support for our early and/or late stage Pharmaceutical R&D Oncology portfolio. GSK Oncology has a commitment to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer, specifically in four areas of cancer research: Cancer Epigenetics, Immuno-Oncology, Oncology Cell & Gene Therapy and Synthetic Lethality.
Global Regulatory Affairs, Oncology Our Global Regulatory Affairs (GRA) Therapeutic Group in Pharmaceutical R&D develops global regulatory strategies to deliver our innovative portfolio. We are strategic partners with other functions in R&D and Commercial in delivering and maintaining our product pipeline, whilst complying with Health Authority regulations. We share learnings and best practices to foster continuous improvement. We strive to shape the evolving regulatory environment and influence policies/guidelines in areas that are key priorities for GSK.
We operate by fostering strong global teamwork and building trusting relationships with internal and external partners, including Regulatory Agencies. We use our leadership, strategic thinking, smart risk-taking skills, global regulatory acumen, analytical ability, communication and influencing skills to advise our internal partners and negotiate with external stakeholders.
We believe in life-long learning and developing our people. We take ownership of our development, as driven by on-the-job experiences, interactions with people, formal instruction and access to learning resources, with support from our leaders.
Key Responsibilities include, but are not limited to:
- Serving as an empowered Global Regulatory Lead and/or Regional Lead for assigned assets.
- Leading development of appropriate global and/or regional regulatory strategy and its execution consistent with the overall Medicines Development Strategy.
- Acting as a key strategic partner with the R&D and commercial teams and working closely with the broader regulatory matrix team to conceive and deliver innovative regulatory strategies for assigned assets
- Integrating aspects of strategic and operational regulatory affairs into asset development collaborating with the cross functional team including clinical research, biostatistics, nonclinical, CMC, diagnostics/device, etc.
- Leading preparations and delivery of regional Health Authority interactions, clinical trial applications and marketing authorizations with the cross functional development and regulatory team
- Proactively counsel teams and interpret health authority feedback, regulatory precedent, guidelines and policy to drive the product strategy, as well as driving or supporting efforts to shape the regulatory environment
- Direct line management responsibility
- Ability to attract talent, challenge, manage and develop direct reports
About You: To deliver in this role you will need to combine technical experience, as outlined below, with excellent communication skills, both written and verbal. You will have proven ability to deliver key communications with clarity, impact and passion. You will have proven negotiation skills and will be able to apply these across all levels within the organisation and with external stakeholders, including regulatory agencies. You will be a multi-tasker, who can balance multiple projects simultaneously and proactively plan your work, and the work of project teams, for the most successful results.
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Bachelors or advanced degree in appropriate scientific or clinical discipline
- Proven ability leading global development, submission and approval activities, including leading health authority interactions specialising in Oncology / Haematology.
- Extensive knowledge of clinical trial and Oncology marketing authorization requirements in all major countries
- Proven ability to think strategically and integrate regulatory science with scientific/clinical knowledge
- Strong RA team leadership experience/capabilities evidenced on your CV
- Demonstrated ability to foster strong matrix team working in a global team environment
- Master's Degree or PhD (or equivalent)
- Extensive pharmaceutical industry regulatory experience in development and life-cycle management. Experience in all phases of the drug development process in regulatory affairs
- Experience in working with strategic partners/cross company collaborations
- Experience in partnering with business development in due diligence efforts
- Line management experience of high performing Regulatory Affairs teams.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses (Pharmaceuticals, Vaccines & Consumer Health) research and deliver innovative medicines, vaccines and consumer healthcare products. We are committed to overcoming some of the biggest challenges in global health; delivering products of value in a responsible, sustainable way; and providing access to medicine for the world's poorest communities.
In Pharmaceuticals, our approach to R&D focuses on science related to the immune system, and the use of genetics and investments in advanced technologies (view video to learn more about our strategy). We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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