Director, RA Global Regulatory Strategy

About the role

The Director, Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. They lead the Global Regulatory Product Team (GRPT) and may lead the Labeling Regulatory Strategy Team (LRST).

Responsibilities

• Interfaces with the LRST and AST to implement cross-functional company objectives.
• Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
• Accountable for ensuring that corporate goals are met. Acts as key internal leader and driver of regulatory policy and strategy for assigned products. Leads preparation and maintenance of global regulatory product strategies for assigned products.
• May participate in regulatory and Company initiatives. May influence the development of regulations and guidance. Analyzes legislation, regulations and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
• Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department.
• Under direction from supervisor, ensures alignment of global regulatory strategies with Sr. Management. Presents meaningful regulatory assessments and regulatory recommendations to executive management with informed regulatory opinion based on experience and expertise.
• Under direction from supervisor, makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management.
• Follows budget allocations and keeps supervisor informed on project resourcing.

Requirements

• Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).
• Preferred Education: Relevant advanced degree is preferred. Certification a plus.
• Required Experience: 5+ years of regulatory experience. Some portion may include relevant exposure to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Proven 3+ years in a strategic leadership role with strong project management skills. Experience working in a complex and matrix environment, and with multiple stakeholders. Experience interfacing with government regulatory agencies.
• Strong communication and proactive negotiation skills. Business acumen and able to work under pressure.
• Preferred Experience: 7+ years experience in pharmaceutical regulatory activities; preferably in at least 2 regions/major countries. Experience developing and implementing successful global regulatory strategies. Drug development experience preferred. Strong clinical foundation preferred.

Qualifications

• Required: Bachelor's degree in life sciences.
• Preferred: Relevant advanced degree.
• Required: 5+ years of regulatory experience.
• Preferred: 7+ years experience in pharmaceutical regulatory activities.

Skills

• Strategic thinking and problem-solving.
• Excellent communication and negotiation skills.
• Experience with global regulatory frameworks.
• Project management and leadership skills.
• Ability to work in a matrixed environment.
• Knowledge of pharmaceutical industry regulations and guidelines.

Benefits

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

Pay

$160,500 - $305,000 USD

Schedule

Hybrid