Director, Global Regulatory Project Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the translation and execution of global regulatory strategies throughout drug development initiatives.

• Provide guidance to Global and Regional Regulatory Leads on product development, submissions, and lifecycle management.

• Lead intricate IND/CTA, NDA/BLA/MAA regulatory submissions spanning various regions.

• Convert regulatory strategies into actionable project plans and drive effective operational execution.

• Organize cross-functional meetings and monitor submission activities.

• Identify potential risks, suggest solutions, and manage critical submission challenges.

• Oversee the preparation and submission of investigational and marketing registration documentation.

• Foster partnerships with clinical, medical, safety, CMC, and commercial teams.

• Facilitate negotiations and collaboration with cross-functional teams and regulatory authorities.

• Mentor and develop junior and mid-level staff members.

• Advocate for enhancements in regulatory project-management processes.

• Develop and implement regulatory processes and policies.

⛳️ Requirements

• Bachelor's degree in Science or a related field.

• At least 10+ years of experience in regulatory project management and submissions.

• Experience with both small molecules and biologics.

• Significant global experience.

• Proven strategic regulatory leadership and successful submissions across multiple regions.

• Experience in leading cross-functional and cross-regional teams.

• Strong business acumen and strategic thinking capabilities.

• Ability to synthesize multiple data sources for effective decision-making.

• Exceptional verbal and written communication skills.

• Capacity to comprehend and translate complex regulatory issues.

• Skills in conflict resolution and negotiation.

• Proficient with project management and document management tools, including Smartsheets, MS Project, and Power BI.

• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

• Ability to learn and adapt to new software platforms and digital collaboration tools.

• Preferred experience with electronic document management systems and regulatory submission platforms.

• An advanced degree is preferred.

• PMP or similar certification is preferred.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Occasional travel, both international and domestic, may be required.