Senior Regulatory Operations Lead: Submissions & RIM
Parabilis Medicines
Parabilis Medicines is seeking a Senior Manager/Associate Director, Regulatory Operations to lead global regulatory submissions, information management, and publishing initiatives. You will drive Veeva RIM implementations and collaborate across Regulatory Affairs, Medical Writing, Clinical Development, CMC, and Quality to ensure compliant, timely submissions. The role emphasizes strong technical regulatory operations expertise, process improvement, and partnering with external providers. #J-18808-Ljbffr Parabilis Medicines
- A leading pharmaceutical company is looking for a Medical Writing Operations Manager to ensure high-quality, submission-ready documents. The role includes reviewing and formatting documents... ...field and at least 4 years of regulatory document experience in biotech or pharma...SeniorRegulatoryContract work
- A leading biotechnology company in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure timely delivery of regulatory documents. The ideal candidate...SeniorRegulatory
- A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis...SeniorRegulatory
- Lilly is seeking an Associate Director-Medical Writer to lead and drive the development of high-quality regulatory and scientific documents for submissions and internal communications. You will coordinate with clinical development, regulatory, biostatistics, medical affairs...SeniorRegulatory
- Biogen operates a hybrid role in the Cambridge/Durham area seeking a Senior Analyst, Statistical Programming to lead programming activities and oversee vendor work, delivering submission-ready outputs with minimal supervision... ...with CDISC and regulatory guidelines across...SeniorRegulatory
- Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule. You will manage a portfolio of submissions...SeniorRegulatory
- ...Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract... ...mentor junior staff, and collaborate across functions to ensure timely, high-quality submissions. #J-18808-Ljbffr Alnylam PharmaceuticalsSeniorRegulatoryContract work
- Alnylam Pharmaceuticals is looking for a Senior Manager, Medical Writing to join our team in Cambridge, Massachusetts. This role... ...6 years of medical writing experience, familiarity with regulatory submissions, and excellent project management skills. A comprehensive benefits...SeniorRegulatoryContract work
$78.94k - $126.4k
...looking for a research administrator at Brigham and Women's Hospital in Boston. This role supervises lab operations, manages personnel, and ensures compliance with regulatory standards. The ideal candidate will hold a Bachelor’s Degree and possess 3-5 years of relevant...SeniorRegulatory- Xenon Pharmaceuticals Inc. in Needham/Boston, MA seeks a Senior Manager, Trial Operations to lead Phase 3 trial delivery from start-up to closeout. Partners with Clinical Development, CMC, Regulatory Affairs and external vendors to drive strategy, risk management and high...SeniorRegulatoryRemote job
- ...Pharmaceuticals seeks an Associate Director, Shift Quality Operations to lead real-time QA on aseptic cell therapy manufacturing on-site in... ...investigations and CAPAs, ensuring inspection readiness and regulatory compliance across shifts while partnering with Manufacturing...SeniorRegulatoryShift work
- Amylyx Pharmaceuticals, Inc. is seeking a Senior Manager, Marketing Operations to lead operational execution across congress activities, marketing events... ...You will collaborate with Marketing, Medical, Legal, Regulatory, and Procurement to ensure compliant, high-quality...SeniorRegulatoryRemote job
- Key Responsibilities Provide operational leadership supporting global regulatory submissions from planning through archival Serve as the business lead for Regulatory Information Management and Veeva RIM Basics Partner with cross-functional stakeholders to implement...SeniorRegulatory
- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The... ...with cross-functional teams. This mid-senior position focuses on ensuring timely, compliant...SeniorRegulatoryFull time
$106k - $130k
A biotech company is seeking a Regulatory Affairs Senior Associate in Boston. The role focuses on supporting regulatory activities for innovative therapeutics in neuromuscular conditions. Candidates should have a bachelor's degree in a scientific discipline, 2+ years in...SeniorRegulatory$145k - $175k
...medicines. The company's lead investigational medicine... ...a highly skilled Senior Manager/Associate Director, Regulatory Operations to support and help drive... ...supporting global regulatory submissions, regulatory information... ...and optimization of Veeva RIM Basics while helping...SeniorRegulatoryShift work- ...opportunity to shape global regulatory strategy and... ...Global Regulatory Leads to drive globally... ...thinking with operational execution across all... ...teams and senior leadership to drive... ...process efficiency, and submission readiness. • Prepare... ...Management (RIM) #LI-LB1 #LI-REMOTE...SeniorRegulatoryWork at officeRemote workWork from homeWorldwide
- Senior Manager - Regulatory Affairs Operations Location - Cambridge, MA (Hybrid) Oncology Biotech... ...number of regulatory submissions and interactions with global... ...as Regulatory Operations Lead for submission planning and... ...systems (e.g., Veeva RIM) Experience supporting major...SeniorRegulatory
- Clinovo is seeking a Clinical Trial Manager to lead trials from startup through closeout in a fast-paced biotech setting. The role emphasizes operational oversight, budgeting, timelines, and regulatory compliance with a strong emphasis on collaboration across Clinical...SeniorRegulatory
- ...organized and collaborative Regulatory Affairs Generalist / Senior Associate to support a... ...excellence across clinical, submission, and post‑approval... ...cross functionally to ensure operational excellence in regulatory... ...Information Management (RIM) systems, electronic document...SeniorRegulatoryLocal areaRemote work
- Xenon Pharmaceuticals Inc. in Needham/Boston, MA seeks a Senior Manager, Trial Operations to lead Phase 3 clinical trial delivery from start-up to... ...yet hands-on role partners with Clinical Development, Regulatory Affairs, CMC and external vendors to ensure high-quality...SeniorRegulatory
$235k - $330k
Kymera Therapeutics is seeking a Senior Director of Clinical Operations in Boston, MA. This leadership role oversees all aspects of clinical operations... ..., managing a clinical operations team, and ensuring regulatory compliance. The ideal candidate has over 12 years of experience...SeniorRegulatory$210k - $320k
...biotechnology company committed to establishing the leading, fully integrated platform for precision... ...the lifecycle of the product from IND submission through BLA approval. The candidate will... ...secondary suppliers.Work directly with regulatory and key stakeholders on the development...SeniorRegulatoryFull time- ...Pharmaceuticals is seeking an Associate Director, Marketing Operations to lead the orchestration of marketing operations across rare disease... ...‑functional collaboration with Commercial, Medical Affairs, Regulatory, Legal and Finance. The successful candidate will champion...SeniorRegulatory
- Vertex Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development and lifecycle programs,... ...modern tooling like MS Project, Smartsheet, and Veeva RIM in a hybrid work environment. #J-18808-Ljbffr Vertex...Regulatory
- ...Senior Vice President, Global Regulatory Affairs About the Company A clinical-stage biotechnology company... ...a hands-on approach, capable of leading the team in interactions with global... ...regulatory documentation and submissions, providing strategic direction for...SeniorRegulatory
- ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...SeniorRegulatory
$155k - $185k
...and daily lives.We are looking for a Senior Program Manager, SaMD to join our growing... ...on end-to-end SaMD programs and can operate effectively within an established but... ...product lifecycle, from development through regulatory submission and launchPartner with Machine...SeniorRegulatoryFull timeWork at officeRelocation- Sanofi in Cambridge, MA seeks a senior toxicologist to lead nonclinical safety programs across drug... ...with global project teams to ensure regulatory readiness and high scientific standards... ...ICH experience, and a track record of IND/CTD submissions. #J-18808-Ljbffr BioSpaceSeniorRegulatory
$230k - $281k
...their source. REM‑422 is our lead program and our near‑term... ...Remix is seeking a Senior Director, Clinical Operations to lead our clinical operations... ...: protocols, IND submissions, Investigator Brochures,... ...study reports. Partner with Regulatory Affairs and Biostatistics...SeniorRegulatory
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