Head, Global Regulatory Affairs, Oncology

Posted 01 Aug 2019

Billerica, Massachusetts - United States

Req Id 195581

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your Role:  

The Global Regulatory Affairs (GRA) is responsible for regulatory strategy and Health Authority liaison activities for development products. A significant focus of the development pipeline is in the area of oncology and immuno-oncology. The GRA Oncology Head is responsible for managing a team of regulatory leaders driving our oncology programs, ensuring the development of, and supervising regulatory strategies our oncology portfolio. The GRA Oncology Head is a key member of the GRA Leadership Team, a Key Member of the Oncology Franchise Leadership Team, and participate in several governance meetings dedicated to development strategies and operational decision-making. The GRA Oncology Head is a Leader in the field of Regulatory Affairs-Oncology, a Leader in driving the GRA Oncology Regulatory Team, and a Leader in demonstrating a high degree of collaboration within GRA, and outside GRA. The GRA Oncology Head is a champion in ensuring continuous improvement and bringing creativity to Regulatory Affairs, in line with the changes in the Regulatory Environment, and is able to influence these changes. The GRA Oncology Head is the voice of GRA for oncology products throughout life-cycle management.

 

Who you are:  

  • Advanced diploma (PhD, PharmD, MD) and at least 15 years of relevant regulatory experience
  • A minimum of 7 to 10 years of recent oncology experience leading and managing global teams
  • Experienced strategist with a record of successful FDA interactions supporting significant oncology submissions, including original NDAs/BLAs, efficacy supplements
  • A strong leader that participates in the overall GRA strategy, collaborate with peers on the GRA & RDQ Leadership Team to create a united environment and serve as a role model for GRA & RDQ employees.
  • As a strong Leader, the Head is experienced in hiring, monitoring performance, and deploying staff and regulatory teams as the portfolio evolves, and has the ability to develop people and put in place a stable environment where succession planning is a key element of strength of the whole organization.
  • Skilled at attracting, developing, and maintaining talent
  • Ability to travel domestically and internationally as needed
  • Manage a team of professionals responsible for regulatory strategy, submissions, and health authority liaison activities for the Company’s oncology/immuno-oncology portfolio from the initiation of development through to commercialization. In this context, creating an environment that attracts, develops, and maintains high quality talents is essential.
  • Ensure consistent roles, responsibilities, and clear accountability for staff, aligned with the GRA operating model, ensuring that each Oncology Regulatory Leader responsible for a program has the ability to run the cross-functional regulatory team that is necessary in order to deliver globally on the R&D regulatory strategies.
  • For development programs, the Oncology Regulatory TA Head is an essential partner for R&D functions, from CMC to Global Early and Late Clinical Development, Drug Safety, Medical, and Launch Teams.
  • Ensure successful registration of oncology development assets.
  • Participate in cross-functional and GRA initiatives; build partnership and optimize effective working relationships, shape the regulatory contribution and influence

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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