Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Regulatory Operations Leader - eCTD/Submissions

$160k - $240k

Rhythm 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

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Operations Leader - eCTD/Submissions in Boston, MA vacancy
  •  ...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... 
    Senior
    Regulatory
    Work at office

    Xenon Pharmaceuticals Inc.

    Needham Heights, MA
    1 day ago
  • $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... 
    Senior
    Regulatory
    Flexible hours

    Akebia-Therapeutics-

    Cambridge, MA
    5 days ago
  •  ...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... 
    Senior
    Regulatory

    JobRx, Inc.

    Boston, MA
    1 day ago
  • 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

    Monte Rosa Therapeutics Inc.

    Boston, MA
    2 days ago
  •  ...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 LLP
    Senior
    Regulatory

    RBW Consulting LLP

    Boston, MA
    2 days ago
  • 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

    Monte Rosa Therapeutics, Inc

    Boston, MA
    1 day ago
  • 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... 
    Senior
    Regulatory

    AstraZeneca GmbH

    Boston, MA
    4 days ago
  •  ...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:... 
    Senior
    Regulatory

    Careers Integrated Resources Inc

    Lexington, MA
    4 days ago
  •  ...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... 
    Senior
    Regulatory
    Contract work

    Planet Pharma

    Cambridge, MA
    2 days ago
  • 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

    Mass Digital Health

    Cambridge, MA
    2 days ago
  •  ...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

    Aveo Pharmaceuticals Inc

    Boston, MA
    3 days ago
  •  ...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... 
    Senior
    Regulatory
    Temporary work
    Work at office
    Worldwide
    2 days per week

    Xenon Pharmaceuticals Inc.

    Needham Heights, MA
    1 day ago
  •  ...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... 
    Senior
    Regulatory

    Kiniksa Pharmaceuticals

    Lexington, MA
    1 day ago
  • $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...
    Senior
    Regulatory
    Remote job
    Flexible hours

    Praxis Precision Medicines, Inc.

    Boston, MA
    1 day ago
  • $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... 
    Senior
    Regulatory

    WHOOP

    Boston, MA
    5 days ago
  •  ...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... 
    Senior
    Regulatory
    For contractors
    Immediate start
    Day shift

    Guru Schools

    Woburn, MA
    2 days ago
  • $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... 
    Senior
    Regulatory
    Work at office

    Sarepta Therapeutics

    Cambridge, MA
    7 days ago
  • 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

    Verastem Oncology

    Boston, MA
    1 day ago
  •  ...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-... 
    Senior
    Regulatory
    Remote work

    The Fountain Group

    Boston, MA
    1 day ago
  • $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... 
    Senior
    Regulatory
    Temporary work
    Work at office
    Local area
    Immediate start
    3 days per week

    Kids For The Future

    Waltham, MA
    1 day ago
  • $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... 
    Senior
    Regulatory
    Permanent employment
    Local area
    Relocation package
    2 days per week

    Payfuture Technologies

    Cambridge, MA
    2 days ago
  • $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... 
    Senior
    Regulatory

    Eversource

    Boston, MA
    2 days ago
  •  ...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... 
    Senior
    Regulatory

    Kids For The Future

    Waltham, MA
    1 day ago
  •  ...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... 
    Senior
    Regulatory

    Initial Therapeutics, Inc.

    Boston, MA
    1 day ago
  • $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... 
    Senior
    Regulatory
    Work at office
    Remote work

    Ionis Pharmaceuticals Inc

    Boston, MA
    2 days ago
  •  ...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... 
    Senior
    Regulatory

    Scorpion Therapeutics

    Cambridge, MA
    5 days ago
  •  ...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... 
    Senior
    Regulatory
    Remote work

    Barrington James

    Boston, MA
    2 days ago
  •  ...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... 
    Senior
    Regulatory
    For contractors

    Verastem

    Boston, MA
    3 days ago
  • $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... 
    Senior
    Regulatory

    Eli Lilly

    Boston, MA
    1 day ago
  • $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... 
    Senior
    Regulatory

    WHOOP

    Boston, MA
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Operations Leader - eCTD/Submissions. Be the first to apply!