Associate Director, Global Regulatory Project Management

Employer Industry: Pharmaceutical Development

Why consider this job opportunity:

• Salary up to $194,600 annually
• Participation in an annual bonus plan for non-commercial roles and incentive compensation for commercial roles
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs
• Opportunity to own shares of the employer's stock through discretionary equity awards and the Employee Stock Purchase Plan
• Chance to work in a collaborative and high-performance culture that values strategic leadership and innovation

• Translate, implement, and advise on global regulatory strategies for development programs across major regions
• Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) ensuring compliance with international requirements
• Organize and facilitate cross-functional meetings to coordinate and track submission activities globally
• Identify risks and manage critical issues related to global regulatory submissions and strategy
• Mentor and guide junior staff in project planning and regulatory processes

• Bachelor’s degree in Science or related discipline; advanced degree preferred
• Minimum 8+ years of experience in regulatory project management and submissions, with significant global exposure
• Proven track record of successful submissions and regulatory project management accomplishments in multiple regions
• Strong verbal and written communication skills, able to convey complex regulatory issues clearly
• Proficiency with project management and document management tools (e.g., Smartsheets, MS Project, Power BI)

• PMP or similar certification
• Experience leading cross-functional and cross-regional teams
• Strong business acumen and strategic thinking skills
• Ability to integrate multiple sources of data for sound decision-making
• Skilled in conflict resolution and negotiation

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