Associate Director, Regulatory Operations Global Submission Management

Role Summary

Role: Associate Director, Regulatory Operations Global Submission Management. We are looking for an experienced and highly organized Global Submission Associate Director to join our Global Regulatory Affairs team. In this key role, you will lead and manage the planning, compilation, and delivery of high-quality regulatory submissions to health authorities while supporting global initiatives. Location: Conshohocken, PA / Waltham, MA.

Responsibilities

• Submission Leadership: Plan, manage, and execute complex regulatory submissions (e.g., IND, NDA, MAA, variations, renewals, responses to questions) for Global markets.
• Global Collaboration: Act as the US regulatory submissions expert within global submission teams, ensuring alignment with global strategies and timelines.
• Agency Interface Support: Support interactions with the FDA, national competent authorities, and Health Authorities during the review process.
• Quality Oversight: Ensure submissions are prepared according to current regulatory standards (eCTD format) and company SOPs.
• Timeline Management: Develop detailed submission plans and track key milestones to ensure on-time delivery of high-quality regulatory dossiers.
• Process Optimization: Contribute to the development and improvement of global submission processes, templates, and best practices.
• Training and Guidance: Provide mentorship and guidance to submission coordinators and junior staff
• Regulatory Intelligence: Monitor and assess changes in regulatory requirements that impact submission strategies and advise relevant teams accordingly.

Qualifications

• Bachelor’s degree in Life Sciences or a related discipline (advanced degree preferred).
• 8+ years of experience in R&D.
• Solid knowledge of submission processes, procedures, and eCTD format.
• Experience managing major submissions (e.g., INDs, NDA, RFIs).
• Strong understanding of regulatory operations systems (RIMS, EDMS, publishing platforms).
• Demonstrated ability to lead complex projects and cross-functional teams in a global environment.
• Excellent written and verbal communication skills in English
• Detail-oriented with strong organizational and project management skills.