Director Regulatory Affairs, Tactical Implementation

Role Summary

The Regulatory Affairs Lead for the Tactical Implementation Team will lead the regulatory team responsible for the execution of regulatory activities across assigned programs and markets. This role ensures timely and compliant preparation, submission, and maintenance of regulatory filings throughout the product lifecycle, including regulatory writing. The Lead serves as a key interface between strategic regulatory leadership and cross-functional stakeholders to ensure successful delivery of regulatory objectives.

Responsibilities

• Lead and develop a team responsible for the tactical execution of global regulatory submissions (e.g., INDs/CTAs, NDAs/BLAs, MAAs, variations, amendments, annual reports).
• Collaborate with strategic regulatory leads in translating regulatory strategy into actionable plans and deliverables.
• Manage preparation and medical writing of regulatory documents and meeting briefing materials.
• Oversee submission planning, preparation, quality control, and tracking in alignment with project timelines and regulatory requirements.
• In collaboration with regulatory strategists, act as regulatory point of contact for cross-functional teams to ensure seamless operational execution of regulatory submissions.
• Provide oversight into the preparation and review of high-quality regulatory documents and ensure accuracy, consistency, and adherence to agency expectations.
• Monitor regulatory intelligence and guidance relevant to operational execution; ensure internal processes and deliverables remain aligned with current regulations.
• Contribute to the development and continuous improvement of regulatory systems, tools, templates, and procedures to enhance submission quality and efficiency.
• Represent the Tactical Implementation Team in internal governance, regulatory planning, and operational working groups.

Qualifications

• Required: Bachelor’s degree in life sciences or related field.
• Preferred: Advanced degree (MS, PhD, PharmD).
• Required: Minimum of 8 years of experience in Regulatory Affairs, including hands-on experience with regulatory submissions in multiple regions (US, EU, and/or other international markets).
• Required: Strong understanding of global regulatory requirements and submission formats (eCTD).
• Required: Demonstrated experience managing complex regulatory deliverables across product lifecycle stages.
• Required: Excellent project management, communication, and organizational skills.
• Required: Proven ability to work collaboratively across cross-functional teams and in a matrix environment.
• Preferred: Prior experience in people or project team leadership.

Additional Requirements

• Travel (approximately 15%) may be required.