Director, RA Global Regulatory Strategy

About the role

The Director, Regulatory Affairs, 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 (GRPT) and the Labeling Regulatory Strategy Team (LRST).

Responsibilities

• Interfaces with the LRST and AST to lead and support cross-functional company objectives.
• Leads the GRPT to develop creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products.
• Ensures strategic messaging and content of global regulatory dossiers are included and clear.
• Accountable for ensuring corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
• Prepares global regulatory product strategies for assigned products and leads the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
• Manages projects and necessary documentation of reg strategies.

Requirements

• Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• Required Experience: 7+ years regulatory experience, some portion may include experience related to pharmaceutical regulatory work, proven 5+ years in a strategic leadership role with strong project management skills, experience working in a complex and matrix environment with multiple stakeholders and influencing cross-functional teams, experience interfacing with major government regulatory bodies.
• Preferred Experience: 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.

Qualifications

• Strong communication and proactive negotiation skills.
• Experience developing and implementing successful global regulatory strategies.

Skills

• Strategic thinking and problem-solving.
• Excellent project management and organizational skills.
• Ability to influence and collaborate with cross-functional teams.
• Knowledge of global regulatory frameworks and processes.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) plan

Pay

$182,000 - $346,000 USD

Schedule

Hybrid