European Union Regulatory Affairs, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
A newly created role, the Global Regulatory Strategy Leader (GRSL) Vaccines will be responsible for developing and implementing global regulatory strategies to advance the development of vaccine candidates in the Gates MRIportfolio. The GRSL Vaccines will be a recognized expert in global vaccine regulatory affairs, have direct involvement with the development and licensure of vaccine candidates worldwide and must be comfortable working cross-functionally on product development teams, representing GRA. The incumbent will be responsible for developing, documenting and updating the regulatory functional plans and all Health Authority engagement plans required to progress the Gates MRI portfolio of vaccine candidates from early preclinical development to human proof of concept and beyond.
As a member of the vaccine core team(s), the GRSL will be a key participant in the decision making, will have accountability for the strategic regulatory direction and help build the new organization. The GRSL will also participate in due diligence and partnering activities, building for the future.
The successful candidate will be an innovative, sophisticated, and collaborative leader who thrives in a “get it done” type of environment with a strong track record of hands-on experience in Regulatory Strategy with the following mix of personal and professional characteristics:
10+ years of experience in product development in industry, with 8+ years of that experience being in regulatory strategy.
Minimum of MS but high preference for advanced degree (PhD, MD) in a related scientific field.
Vaccine regulatory experience is essential.
Internal Number: 830
About The Higgins Group
Finding the best people and boosting their impact
The Higgins Group, Inc. is an executive search and consulting firm focused exclusively in the life sciences. For over two decades we’ve been helping our clients thrive by going beyond recruiting the best leaders: as a strategic partner we consult on organizational issues that affect executive integration, retention, and performance. This approach has led to long-lasting relationships with a select roster of global pharmaceutical and biotech clients, helping us to grow exclusively through referrals since 1998.
Today, we offer three practices to help our life sciences clients improve performance, retain talent, and accelerate ROI:
Our Executive Search Practice specializes in finding physicians and R&D executives with the credentials, qualities, and cultural fit to drive superior company performance.
Our Leadership Development Practice boosts performance with executive coaching and customized workshops to integrate new executives and create sustainable leadership improvements in individuals and teams.
Our Board Impact Practice enhances board decision-making by recruiting and developing diverse, high-performing leaders who can ...help guide life sciences firms to realize their vision.
All three practices are based on a simple, powerful premise: great leaders drive great performance.