Associate Director, Global Regulatory Project Management

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

📋 Description

• Translate, implement, and provide guidance on global regulatory strategies pertaining to drug development programs.

• Offer strategic regulatory oversight for global product development, submissions, and lifecycle management.

• Lead and manage intricate IND/CTA, NDA/BLA/MAA regulatory submissions across various regions.

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

• Coordinate cross-functional activities to ensure timely delivery.

• Organize and facilitate global cross-functional meetings.

• Identify potential risks, propose solutions, and manage critical issues related to regulatory submissions.

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

• Foster partnerships with senior stakeholders as well as clinical, medical, safety, CMC, and commercial teams.

• Liaise and negotiate with cross-functional teams to accelerate submissions and resolve regulatory challenges.

• Mentor and provide guidance to junior staff members.

• Advocate for process optimization and contribute to regulatory processes and policies.

• May supervise Regulatory Project Management staff and oversee global cross-functional project teams.

• Occasional travel may be necessary to support global project teams, regulatory meetings, and industry conferences.

⛳️ Requirements

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

• A minimum of 8+ years of experience in regulatory project management and submissions.

• Familiarity with both small molecules and biologics.

• Significant experience on a global scale.

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

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

• Strong business acumen coupled with strategic thinking abilities.

• Capability to integrate various data sources for informed decision-making.

• Excellent verbal and written communication skills.

• Proficient in conflict resolution and negotiation.

• Familiarity with Smartsheets, MS Project, Power BI, and Microsoft Office.

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

• Prior experience with electronic document management systems and regulatory submission platforms is preferred.

• PMP or similar certification is preferred.

• Occasional domestic and international travel may be required.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-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 programs.