Senior Manager/Associate Director - Regulatory Operations
About the position As the Senior Manager/Associate Director, Regulatory Operations, you will be responsible for the execution of Regulatory Submissions operational activities in support of our program(s), ensuring adherence to current electronic submission guidelines/requirements. This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and oversight of our electronic submissions (eCTD) vendor, and management of Regulatory archives, submission templates, and Agency correspondence. Support the preparation and submission of Investigational New Drug applications (INDs), Biologic License applications (BLAs), annual reports, Development Safety Update Reports (DSURs), Investigator's Brochure (IB), briefing books to regulatory authorities. This position will report to the Senior Vice President, Regulatory Affairs within the Clinical Development department and be based in Boston, MA or possible remote opportunities within MA, NY, PA, RI, NJ, NC or FL. Your mission Lead and oversee the preparation, formatting, publishing, and submission of regulatory documents for INDs, IMPDs, BLAs, MAAs, and amendments. Ensure submissions are fully compliant with FDA, EMA, Health Canada, and ICH electronic submission standards (eCTD). Provide oversight of regulatory publishing activities, including vendor management and internal coordination, to achieve on-time delivery. Establish and maintain submission trackers, dashboards, and metrics for organizational visibility and audit readiness. Drive best practices in document lifecycle management, including version control, archival, and audit preparedness. Partner with Regulatory Affairs, Clinical, CMC, Quality, and Medical Writing leadership to align submission strategies with development goals. Lead collaboration with IT and external vendors to optimize submission platforms and tools, driving efficiency and compliance. Manage vendor relationships to ensure quality and timeliness of outsourced publishing activities. Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency. Assist in risk assessment and mitigation planning for regulatory deliverables.
Responsibilities
- Lead and oversee the preparation, formatting, publishing, and submission of regulatory documents for INDs, IMPDs, BLAs, MAAs, and amendments.
- Ensure submissions are fully compliant with FDA, EMA, Health Canada, and ICH electronic submission standards (eCTD).
- Provide oversight of regulatory publishing activities, including vendor management and internal coordination, to achieve on-time delivery.
- Establish and maintain submission trackers, dashboards, and metrics for organizational visibility and audit readiness.
- Drive best practices in document lifecycle management, including version control, archival, and audit preparedness.
- Partner with Regulatory Affairs, Clinical, CMC, Quality, and Medical Writing leadership to align submission strategies with development goals.
- Lead collaboration with IT and external vendors to optimize submission platforms and tools, driving efficiency and compliance.
- Manage vendor relationships to ensure quality and timeliness of outsourced publishing activities.
- Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency.
- Assist in risk assessment and mitigation planning for regulatory deliverables.
Requirements
- A bachelor’s degree or related experience is required.
- Minimum of 5 years in the pharmaceutical Regulatory Operations industry.
- Experience managing, and publishing, eCTD submissions to health authorities with knowledge of US, EU, and Canada regional requirements.
- Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance and process are required.
- Experience with Veeva RIM EDMS.
- Highly proficient in Microsoft Office suite.
- Detail-oriented and highly organized.
- Excellent interpersonal skills and ability to develop collaborative partnerships with key stakeholders.
Benefits
- At Tubulis, curiosity and innovation drive us to transform cancer treatment.
- We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.
- Impact that matters : Contribute to breakthrough therapies.
- Global mindset : Work in an international, diverse team.
- Grow & thrive : Develop your career in a supportive, fast-moving environment.
- Innovation every day : Push boundaries with cutting-edge science.
- At Tubulis, your ideas matter, your growth matters—and together, we make a difference.
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