Title: Associate Director, Global Regulatory Strategy
Summary: A global leader in the pharmaceutical industry is seeking a Regulatory Strategy professional to join their team. Acting as the Associate Director of Regulatory Strategy, this role will be vital to the regulatory function, working as a lead in multiple neurology programs. This professional will help develop and implement RA strategy in the life-cycle of both development stage and marketed products in the neurology portfolio. Reporting directly into the Executive Director, Global Regulatory Affairs, this is a key position in a group with high visibility across the organization.
The Associate Director, Regulatory Strategy is responsible for:
- Monitoring and reviewing regulatory submissions activities, partnering with cross-functional teams to ensure high quality and efficiency.
- Act as a key Regulatory Affairs representative with global health authorities for assigned programs, participating in and/or leading health authority interactions.
- Contribute to developing and implementing creative and effective global regulatory strategy for assigned programs. Develop and execute life-cycle management activities of assigned products.
The Associate Director, Regulatory Strategy should have the following qualifications:
- BS/BA Degree with 8+ years of industry experience, alongside 5+ years of Regulatory Affairs experience OR a Master's or PharmD/PhD degree with 6+ years of industry experience and 3+ years of Regulatory experience.
- Experience focusing directly on Regulatory Strategy, developing and carrying out regulatory strategies in the US and ex-US.
- An independent, driven professional with the ability to lead teams and work effectively with cross-functional teams.
- Experience working in Oncology or Neurology preferred.
If you are interested in the Associate Director, Regulatory Strategy role, then please don't wait to apply.