Associate Director, Global Regulatory Affairs

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

📋 Description

• Act as the regulatory liaison on core teams.

• Formulate and strategize regulatory submission plans.

• Coordinate the preparation of submissions to regulatory bodies.

• Execute regulatory intelligence activities.

• Supervise the compilation, review, and submission of regulatory documents, ensuring accuracy, completeness, and timeliness.

• Keep track of the regulatory landscape and relay updates to clinical, regulatory, senior leadership, and other stakeholders.

• Remain informed about global regulatory guidance and regulations.

• Relay significant regulatory updates to senior leadership and project team management.

• Ensure adherence to reporting obligations, including annual and periodic reports.

• Address regulatory inquiries from authorities in collaboration with clinical development, safety, and other subject matter experts.

• Offer strategic regulatory advice for global development and registration initiatives, including INDs, CTAs, NDAs, and MAAs.

• Evaluate and communicate regulatory requirements.

• Contribute to processes and procedures, including drafting internal work instructions and company SOPs.

⛳️ Requirements

• Proven knowledge of regulatory requirements related to the design and execution of clinical trials, including the preparation of regulatory submissions.

• Established understanding of US and international regulatory guidelines and regulations.

• Extensive knowledge of the integrated drug development process.

• Proven ability to identify solutions and alternatives through collaboration, resulting in favorable business outcomes.

• Demonstrated capability to evaluate and manage risk in a highly regulated setting.

• Excellent written, verbal, and presentation communication skills.

• Strong ambition to advance a career in the pharmaceutical industry, eagerness to learn, and a proactive approach to new opportunities.

• Travel anticipated (10-15%).

• Bachelor’s degree with over 10 years of relevant drug development experience OR an advanced degree (such as PhD, PharmD, MS, MBA) with a minimum of 5 years of pertinent drug development experience.

🏝️ Benefits

• Comprehensive health coverage.

• Flexible time off.

• Paid holidays.

• Year-end shutdown.

• Monthly wellness stipend.

• Generous 401(k) match.

• Tuition reimbursement.

• Commuter benefits.

• Disability insurance.

• Life insurance.

• Annual bonus opportunities.

• Equity grants.