Director Regulatory Affairs Strategy

Job Title: Director, Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy

Summary:

The Director, Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. This role leads the Global Regulatory Product Team and ensures strategic messaging and content of global regulatory dossiers.

Essential Duties and Responsibilities:

• Develop and implement global regulatory strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.
• Continually expand therapeutic area knowledge, and ensure strategic messaging and content of global regulatory dossiers.
• Proactively anticipates and mitigates regulatory risks.
• Ensures compliance with global regulatory requirements.
• Manages compounds through all phases of development, including post-approval and throughout the life cycle of the product.
• Demonstrates excellent understanding of drug development and leadership behaviors consistent with level.
• Develops and implements acceleration strategies.
• Manages projects and necessary documentation of reg strategies.

Qualifications:

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• Relevant advanced degree is preferred. Certification is a plus.
• 7+ years of regulatory experience. Some portion may include experience related to pharmaceutical regulatory work
• Requires drug development experience in the US region.
• Proven 5+ years in a strategic leadership role with strong project management skills.
• Experience interfacing with major government regulatory authorities.
• Experience developing and implementing successful global regulatory strategies.

Preferred Qualifications:

• 10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan.
• Strong global drug development foundation with business acumen.