Associate Director Regulatory Operations

Associate Director, Regulatory Operations - Boston, Massachusetts

Opportunity Overview:

My client is a global, commercial-stage biopharmaceutical organisation focused on developing innovative therapies for rare and serious diseases. The company is driven by a strong scientific mission and is committed to improving outcomes for patients with high unmet medical need across multiple therapeutic areas.

They are currently seeking an experienced Associate Director of Regulatory Operations to join their growing Regulatory Affairs function. This individual will be responsible for leading and supporting global regulatory submission activities, ensuring high-quality, compliant, and timely delivery of key regulatory documents across multiple regions.

The role sits within a fast-paced, cross-functional environment and plays a critical part in enabling successful product development and lifecycle management.

Key Responsibilities:

• Lead and oversee regulatory operations activities supporting global submissions across US, EU, UK, and Canada
• Ensure timely, accurate, and compliant preparation of eCTD submission-ready documents in line with regulatory requirements and internal standards
• Coordinate submission activities across Regulatory Affairs, Clinical Development, Quality, Safety, and CMC teams
• Support the preparation and lifecycle management of regulatory filings, including INDs, NDAs/MAAs, DSURs, annual reports, and safety submissions
• Maintain oversight of regulatory commitments, submission tracking systems, and health authority obligations
• Act as a key point of expertise for eCTD publishing standards and submission processes
• Identify and implement process improvements to enhance efficiency and compliance within regulatory operations
• Contribute to the development, review, and maintenance of SOPs and governance documentation
• Support inspection readiness activities and ensure documentation is maintained to audit standards
• Collaborate closely with global stakeholders to ensure alignment of regulatory timelines and deliverables

Candidate Profile:

• Bachelor’s degree in life sciences, pharmacy, or a related discipline
• Experience in Regulatory Affairs Operations within pharma or biotech
• Strong understanding of global regulatory frameworks and drug development processes
• Solid knowledge of FDA, EMA, MHRA, and Health Canada requirements, including CTD and eCTD structure
• Experience working with regulatory information management systems such as Veeva RIM or equivalent EDMS platforms
• Strong proficiency in Microsoft Office tools
• Proven ability to manage multiple priorities in a fast-moving, deadline-driven environment
• Excellent communication skills with the ability to influence and collaborate across functions
• High attention to detail with a strong focus on compliance and quality standards
• Comfortable balancing operational execution with process improvement and strategic input

Additional Information:

The role is based at my client’s corporate office in Boston, Massachusetts and follows a hybrid working model, with regular on-site presence required in line with business needs. Some domestic and international travel may be expected.

A competitive compensation package is offered, including base salary, annual performance-related bonus, and long-term incentive opportunities, alongside a comprehensive benefits offering.