Senior Regulatory Operations Leader - eCTD/Submissions
$160k - $240kRhythm Pharmaceuticals
Rhythm Pharmaceuticals, Inc in Boston is seeking an experienced Regulatory Affairs Operations professional to manage regulatory operations activities and ensure compliance with internal and health authority standards. The ideal candidate will have over 8 years of experience in the pharmaceutical or biotechnology sectors, a Bachelor's degree, and a comprehensive understanding of FDA, EU, and UK regulations. This role supports collaboration across project teams in a hybrid work environment, and offers a competitive salary range of $160,000 - $240,000, along with potential bonuses and benefits. #J-18808-Ljbffr
- ...Xenon Pharmaceuticals Inc. is seeking a Senior Manager for Regulatory Affairs Operations at its Needham, MA office. This role involves supporting global regulatory submissions through effective collaboration with cross-functional teams. Ideal candidates will have over...SeniorRegulatoryWork at office
$246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...SeniorRegulatoryFlexible hours- ...Pharmacy Officer (ACPO) to provide strategic leadership and operational oversight for clinical pharmacy at Boston Children's Hospital... ...will advance clinical excellence and ensure compliance with all regulatory standards. This role requires strong leadership, analytical...SeniorRegulatory
- Monte Rosa Therapeutics Inc. is looking for a Regulatory Operations Manager in Boston, MA. The selected candidate will manage eCTD submissions and oversee collaboration with external vendors to ensure timely submissions. This role demands expert knowledge in document management...Regulatory
- ...lead the development and delivery of high-quality clinical and regulatory documents. This role involves providing scientific leadership... ...in life sciences, and a strong background in clinical development and regulatory submissions. #J-18808-Ljbffr RBW Consulting LLPSeniorRegulatory
- Monte Rosa Therapeutics, Inc is looking for a Regulatory Operations Manager in Boston, Massachusetts. The successful candidate will manage eCTD submissions and oversee external vendors, ensuring high-quality regulatory dossier publishing. Required qualifications include...Regulatory
- AstraZeneca GmbH is seeking an Associate Director - Territory Operations Manager in Boston, MA to lead the cell therapy division. The role... ...overseeing clinical operations, and ensuring compliance with regulatory standards. The candidate should have 8+ years of experience in...SeniorRegulatory
- ...Senior CMC Regulatory Submission Manager A Few Words About Us - Integrated Resources, Inc is a premier... ...project teams to support the execution of operational activity, monitor adherence to the... ..., submission ready standards and eCTD requirements Responsibilities:...SeniorRegulatory
- ...pharmaceutical company is looking for a Medical Writing Operations Manager to ensure high-quality, submission-ready documents. The role includes reviewing and... ...degree in a relevant field and at least 4 years of regulatory document experience in biotech or pharma. The...SeniorRegulatoryContract work
- Mass Digital Health is seeking a Global Submission Lead in Cambridge, MA, or Morristown, NJ. This role focuses on planning, coordination, and execution of regulatory submission activities within the R&D team at Sanofi. The ideal candidate will have over 5 years of experience...Regulatory
- ...JOB TITLE: Executive Director, Regulatory Operations and Submission Management DEPARTMENT: Regulatory... ...functional stakeholders and executive leaders. The Executive Director will serve... ...in global submission standards (eCTD/CTD), strong project/program leadership...Regulatory
- ...About the Role The Senior Manager, Regulatory Affairs Operations supports global regulatory submissions across Xenon’s development portfolio. This role handles submission operations... ...submission/registration management, eCTD & publishing integration, lifecycle management...SeniorRegulatoryTemporary workWork at officeWorldwide2 days per week
- ...Pharmaceuticals is seeking an Associate Director, GMP Quality Assurance Operations in Lexington, MA to oversee quality operations for GMP... ...process, including tech transfers and compliance with global regulatory standards. The ideal candidate will have at least 8 years of...SeniorRegulatory
$130k - $150k
Praxis Precision Medicines, Inc. is seeking a talented Medical Writer to oversee documents for clinical development programs. This role requires at least 4 years of medical writing experience in a Sponsor or CRO setting, along with a Bachelor’s degree in a scientific discipline...SeniorRegulatoryRemote jobFlexible hours$60k - $80k
A performance and wellness company in Boston seeks a Sr. Program Specialist to ensure operational readiness for legal and regulatory requirements. This role involves translating evolving standards into scalable workflows and supports within Membership Services. Ideal candidates...SeniorRegulatory- ...Wehavebelowurgentlongtermcontractprojectimmediatelyavailable for****Senior Business Intelligence Developer, Woburn, MA**** need submissions you please review the below role, if you are... ....• Ensure compliance with organizational and regulatory standards to maintain data integrity.**Skill...SeniorRegulatoryFor contractorsImmediate startDay shift
$136k - $170k
...related to Sarepta's Regulatory Information Management... ...to develop regulatory submissions for dispatch to health... ...authorities globally. The Senior Manager, RIM will have... ...enhancements Operate under medium to low supervision... ...~ Deep knowledge of eCTD publishing, submission...SeniorRegulatoryWork at office- A biopharmaceutical company in Boston seeks a Senior Pharmacovigilance Operations Specialist to manage drug safety case management and compliance.... ...involves overseeing operational activities regarding ICSR submissions, collaboration across functions, and ensuring...Senior
- ...The Fountain Group is seeking an experienced Project Manager (Consultant) in Boston to lead the development and regulatory submission of Class III long-term implantable medical devices. This position requires strong expertise in FDA submissions and management of cross-...SeniorRegulatoryRemote work
$163k - $200k
...professional ambitions. Reporting to the Senior Director, HR Operations & Total Rewards, the Associate... ...Operations is a strategic and hands‑on leader responsible for designing, scaling,... ...data accuracy, efficiency, and regulatory alignment. The Associate Director partners...SeniorRegulatoryTemporary workWork at officeLocal areaImmediate start3 days per week$112.7k - $187.8k
...Manager operational job at Pfizer. Cambridge, MA. ROLE SUMMARY The Senior Manager of Operational Excellence role is an integral... ...status to senior leaders and act as a champion for the... ...legal review and statutory or regulatory clarification, which Pfizer intends...SeniorRegulatoryPermanent employmentLocal areaRelocation package2 days per week$149.6k - $166.22k
...supervise the development and implementation of transmission and distribution System Operations Training in Massachusetts. The role involves overseeing staff, ensuring compliance with regulatory requirements, and assessing training needs. The ideal candidate will have a...SeniorRegulatory- ...Kids for the Future in Waltham, MA is seeking an Associate Director, Regulatory Affairs to lead regulatory activities for product development, particularly focusing on Thyroid Eye Disease. This role requires a proven track record in Regulatory Affairs, strong communication...SeniorRegulatory
- ...Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The... ...lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold a BS/BA in...SeniorRegulatory
$113k - $142.43k
...you develop and expand your career!Senior Regulatory Medical WriterThe Senior... ...findings, and working with Regulatory Operations for publishing and submission.This role reports to the Executive... ...follow style guides, lexicons, and eCTD templates etc.Excellent written, oral...SeniorRegulatoryWork at officeRemote work- ...development plans, studies, and submissions activities (when... ...and resources to ensure operational excellence and alignment... ...other statistics project leaders, and communicate with senior leadership. Mentor... ...statistics in challenging regulatory meetings, key scientific...SeniorRegulatory
- ...A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...SeniorRegulatoryRemote work
- ...combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are... ...of internal reports, regulatory submissions, and ad hoc analyses. Create and... ...Support preparation of data packages, eCTD deliverables, and responses to regulatory...SeniorRegulatoryFor contractors
$187.5k - $275k
...Eli Lilly and Company is seeking a Senior Director of Regulatory Strategy in Boston, MA. This role involves leading the planning and implementation... ...strategies for gene-editing programs, managing submissions, and ensuring compliance with regulatory standards. Ideal...SeniorRegulatory$155k - $185k
...Whoop, Inc. is seeking a Senior Program Manager, SaMD, based in Boston, MA. The role focuses on executing Software as a Medical... ...functional teams to ensure successful delivery from development to regulatory submission. Candidates should have 6+ years of project management...SeniorRegulatory
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