Senior Consultant Regulatory Operations Software Implementation; Remote
Brockton, Plymouth County, Massachusetts, 02301, USA
Listed on 2026-07-17
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Business
Regulatory Compliance Specialist
Replimune is dedicated to transforming cancer treatment by developing therapies that activate a powerful, durable whole‑body anti‑tumor response.
Lead and Manage Publishing Activities for IND, NDA, ANDA, Amendments, Supplements, Responses, Annual Reports, Safety Reports, and Promotional SubmissionsFull‑time position. Lead and manage all publishing activities related to regulatory submissions and reporting documents.
Key responsibilities include overseeing submission‑level and document‑level activities for IND, NDA, ANDA, Amendments, Supplements, Responses, Annual Reports, Safety Reports, and Promotional Submissions.
Regulatory Submission Delivery Manager – IRIFull‑time position. Responsibilities focus on ensuring timely and compliant delivery of regulatory submissions across multiple therapeutic areas, managing cross‑functional teams, and maintaining internal process standards.
Scientific Writer (Onsite Consultant)Full‑time, onsite consultant. PhD or Master’s degree in a science discipline required.
Responsibilities: frame, edit, and refine scientific manuscripts, white papers, technical briefings, and related communications.
Executive Director, Regulatory Operations and Submission ManagementFull‑time, executive role.
- Provide strategic and operational leadership for global regulatory operations.
- Oversee all regulatory submission processes and ensure compliance with regulatory authorities.
- Lead cross‑functional regulatory teams and monitor performance metrics.
Full‑time, manager level.
Focus on precision medicine development for antibody‑driven diseases, targeting pathogenic antibodies and their cellular sources.
Senior Consultant, Regulatory Operations Software Implementation (Remote) – Veeva SystemsFull‑time consulting role supporting implementation of Veeva cloud solutions for life‑science companies.
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- Excellent written and verbal communication skills.
- Strong attention to detail and ability to manage multiple projects.
- Proficient with editing tools and content management systems.
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Lead the launch and global leadership of a new Cell Press journal focused on biotechnology research.
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Same core responsibilities as above, reflecting a higher level of seniority.
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