Director, Regulatory Data Governance & Inspection Readiness
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated is seeking a Director, Regulatory Data to lead strategy, governance, and execution of regulatory data management within Vertex's RIMS. You will oversee data collection, quality oversight, reporting, and inspection readiness, while developing a high-performing team and partnering cross-functionally to support portfolio decisions. The role emphasizes establishing scalable data standards, driving continuous improvement, and ensuring data is complete, traceable, #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated
$192k - $288k
Overview The Director, Regulatory Data is responsible for leading the strategy, governance, execution, and continuous improvement of regulatory data management within... ..., quality oversight, reporting, and inspection readiness of critical regulatory data and documentation...SuggestedRemote work2 days per week- ## Director, Regulatory Data Management (Boston, MA)Applylocations: Boston, MAtime type: Full timeposted... ...for leading the strategy, governance, execution, and continuous improvement... ...quality oversight, reporting, and inspection readiness of critical regulatory data and...SuggestedSummer workRemote workFlexible hours2 days per week
$174k - $212k
...Associate Director, Clinical Data Management Watertown, MA Company... ...development and regulatory path, and each expected... ..., regulatory readiness, and high‑quality execution... ...readiness. Support inspection readiness and maintain... ...archiving, and data governance processes are...Suggested- ...Description As Executive Director, Global Regulatory Affairs CMC Early... ...Chain, and Digital/Data) to align CMC... ...timelines. Ensures governance teams and key stakeholders... ...changes, analytical readiness, control strategy evolution... ...ensure consistent, inspection‑ready documentation....SuggestedTemporary workLocal area
$195k - $275k
...ideal candidate will have over 10 years in the biotech industry and a robust track record in TMF management, ensuring readiness for regulatory inspections. The role demands strong leadership, experience in strategic process improvements, and collaboration across...Suggested- A biotechnology organization is seeking an Associate Director, Global Quality to oversee global quality compliance across R&D. This role involves leading compliance projects, ensuring inspection readiness, and embedding quality processes. Candidates should have a strong...
- ...Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy... ...quality and SOP requirements; maintain audit‑ready regulatory documentation and inspection readiness. Qualifications Bachelor's degree in a...Work at officeLocal area3 days per week
$204k - $245k
...personal and we approach every challenge with radical care. The Director, Regulatory CMC is responsible for leading execution of global CMC... ...a key role in supporting post‑approval submissions, inspection readiness, and ongoing compliance activities. This is a full‑time hybrid...Full timeWork at officeFlexible hours3 days per week- ...Assurance, Clinical Drug Supply, and Regulatory Affairs teams to ensure the... ...Translate complex technical data into clear, concise, and... ...completeness, and submission‑ready standards. CMC Regulatory Strategy... ...with stakeholders to support inspection readiness. Strong...Flexible hours
$229.5k - $310.5k
## Sr. Director, Governance, Risk & ComplianceUnited StatesApply NowFind... ...business, and meet global regulatory obligations.Reporting directly... ..., ensuring alignment with data integrity, validation... ...control requirements, and inspection readiness.* Oversee regulatory and compliance...Full timeTemporary workWork at officeLocal areaFlexible hours$245k - $276k
Senior Director, Clinical Data Management Cambridge, MA Amylyx... ...an experienced team ready to take action because... ...data to support regulatory submissions and key... ...relationships, including governance, performance metrics... ...standards, and lead inspection readiness activities...Work at officeLocal areaRemote work$209.35k - $258.6k
Director, Regulatory Labeling Cambridge, MA • Full‑Time/Regular Job Summary Regulatory Affairs... ...Represent labeling strategy in governance forums and regulatory interactions... ...robust version control, tracking, and inspection readiness across labeling documentation Basic...Full timeWork at officeLocal areaRelocationFlexible hours$270k - $285k
...care. Position Description The Senior Director, Regulatory CMC is responsible for defining and... ...maintaining product supply and inspection readiness. The Senior Director serves as a key... ...Regulatory CMC on cross-functional governance forums, providing clear, risk-based...Full timeWork at office3 days per week- ...position will lead clinical data management activities for... ...analysis, publications and regulatory reports/submissions. Reporting to the Senior Director, Data Management, this position... ...in the study eTMF and are ready for regulatory inspection Use data visualization...Interim role
- ## Director Operations - Clinical Data ManagementApplylocations: Paris: Cambridge... ..., maintain regulatory compliance, and effectively... ..., CAPAs, audit or inspection reports or findings... ...in operational governance with external... ...reliability, and inspection readiness. Promotes a...Flexible hours
- Vertex Pharmaceuticals Inc in Boston is looking for a Director, Regulatory Data to oversee regulatory data management within Vertex’s Regulatory... ...involves leading a team to ensure quality oversight, data governance, and compliance, while enhancing usability of regulatory...
- ...Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing... ...Represents ABBV Regulatory position in interactions at Joint Governance. Makes decisions regarding work processes or operational...Worldwide
- Sanofi is seeking a Director, Customer Data Management Lead, specializing in Payer Data Strategy & Governance. The role involves owning the strategy and execution of Payer MDM function for US Commercial Data Management, ensuring trusted and governed Payer data. This position...
- Mass Digital Health is looking for a Director, Customer Data Management Lead to oversee the Payer data strategy and governance. This role requires a strong background in data management, particularly within life sciences, and the ability to lead a team in ensuring data...Work at office
$131k - $187k
...Senior Clinical Data Manager Repertoire Immune Medicines is a clinical-stage biotechnology... ...through database lock, archival, and regulatory submission support. This individual... ...ensure timely, accurate, complete, and inspection-ready clinical trial data in accordance with...Temporary workWork experience placementWork at officeLocal areaFlexible hours3 days per week$156k - $234k
## Associate Director FP&A, Clinical Accounting & Data AnalysisApplylocations: Boston, MAtime... ...data into executive-ready insights that drive portfolio... ...Champion GAAP compliance and governance excellence across all... ...clinical trial agreements, and regulatory milestones* **Systems...Summer workRemote workFlexible hours2 days per week- Job Title Executive Director, Regulatory Operations and Submission Management... ..., and tracking, document readiness and quality control,... ...metrics, vendor governance, and inspection readiness for regulated systems... ...), driving optimization, data governance, and scalable...
$161.25k - $232.92k
Job title: Director, Customer Data Management Lead, Payer Data Strategy & Governance Location: Cambridge, MA / Morristown, NJ Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and play a vital part in the performance of our entire...3 days per week$225k - $337.5k
The Head of Data & AI Governance and Risk is accountable for ensuring that all enterprise Data, AI... ...high-quality, trusted, and regulator-ready, while enabling innovation to scale safely... ...for Data and AI‑related regulatory, audit, and supervisory engagement. The...Temporary work- Liberty Mutual in Boston is seeking a Director I of Data Solutions to lead a team in delivering scalable data solutions. You will transform ideas into effective data strategies, ensuring high data quality within operational datasets. The ideal candidate is a technical...Remote jobFull time
$135k - $215k
...Opportunity Overview The Senior Manager, Data Management acts as the Lead Data... ...reporting in compliance with GCP, SOPs and regulatory requirements Review data via listings... ...required. Lead data management study inspection readiness activities and the support of submission...Work at office- ...The Regulatory Compliance Director is a key part of the Compliance team, collaborating across all areas... ...and manage and maintain continuous readiness and compliance. The Regulatory Compliance... ...and coordinate regulatory audits, inspections, and surveys conducted by agencies (...Local area
$177k - $278.08k
...patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible... ...new scientific, safety and clinical data, as well as Health Authority... ...initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing...Full timeTemporary workLocal areaWorldwide$185.6k - $278.4k
General Summary The Regulatory Labeling Director will lead the strategic development... ...compliance with labeling governance requirements and... ...including the Company Core Data Sheets (CCDS) and regional... ...questions, negotiations, and inspections) regarding all aspects of...Remote jobFull timeLocal area2 days per week- Vertex Pharmaceuticals is looking for an Associate Director, R&D Quality Regulatory & Risk Integration in Boston. This role is responsible for... ...and a solid understanding of GxP regulations and inspection readiness. You will manage key responsibilities such as translating...
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