Director, Regulatory Strategy - Global Biopharmaceuticals (Hybrid)
A leading global biopharmaceutical company is seeking a Director of Regulatory Strategy to drive regulatory success for complex and high-impact programs. This role is responsible for defining and executing global regulatory strategies, collaborating cross-functionally, and ensuring compliance with evolving international regulatory requirements.
Key Responsibilities:
- Develop and lead global regulatory strategies to support product development and approvals.
- Provide strategic regulatory guidance to cross-functional teams, ensuring alignment with business objectives.
- Oversee regulatory submissions and interactions with global health authorities, including the FDA.
- Serve as the regulatory lead for cross-functional project teams and external partnerships.
- Anticipate regulatory risks, develop mitigation strategies, and adapt approaches to evolving regulations.
- Collaborate with market access and medical affairs teams to support product value strategies.
- Monitor industry trends and lead regulatory due diligence for potential business opportunities.
- Mentor and develop junior regulatory professionals within the team.
Qualifications & Experience:
- Bachelor's degree in a scientific discipline required; an advanced degree (PharmD, PhD, MD) is a plus.
- 8+ years of experience in the pharmaceutical or biotechnology industry, with at least 6 years in regulatory affairs.
- Strong knowledge of global regulatory requirements and the drug development lifecycle.
- Experience with regulatory submissions and interactions with health authorities.
- Proven leadership in cross-functional teams with excellent communication and problem-solving skills.
- Ability to thrive in a hybrid work environment and manage multiple priorities.
This is an exciting opportunity to lead regulatory strategy within a dynamic and fast-paced environment. If you are a seasoned regulatory professional looking to make a strategic impact, we encourage you to apply.
