Nonclinical Writing Manager — Regulatory Submissions
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals in Cambridge, MA is seeking a Manager, Nonclinical Writing to provide submission support for scientific staff and lead the preparation of nonclinical content for regulatory filings. You will represent Nonclinical Writing on project teams, collaborate across Early Development, Research, Clinical, Medical Writing, and Regulatory Affairs, and manage internal and outsourced writing resources to ensure high-quality documents. #J-18808-Ljbffr Alnylam Pharmaceuticals
$185.5k - $344.5k
...leading the implementation of tracking, management, and data analytics software (eg,... ...ensuring SEND (Standard for Exchange of Nonclinical data) datasets are of high-quality and are ready in a timely manner for regulatory submissions, which includes SEND datasets from external...SuggestedFull time$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory... ...including for regulatory submission documents and Health Authority... ...Counsels and advises senior management on status of global... ...verbal presentations and in writing regulatory strategy plans and...SuggestedFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$220k - $249.71k
...importantly, while experience within a Regulatory Writing department at a growing biotech is... ...and support documentation planning and submission activities.This high-impact role will... ...ResponsibilitiesLeads the planning and management for the authoring of regulatory submission...SuggestedWork at office$134k - $149k
...passionate about science to join our Regulatory Strategy team. As Senior Manager of Regulatory Affairs, the... ...solid grasp of effective regulatory writing fundamentals and ability to communicate... ...identifying the critical path for submissions, and partnering with functional...SuggestedWork at officeLocal areaFlexible hours3 days per week- ...Solutions team This role develops regulatory strategies for existing, new... ...) products This role manages and submits 510ks for the products... ...and manages regulatory submissions, including 510(k) submissions... ...skills Prior technical writing experience and proven track...SuggestedWork at office
- ...is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance... ...-on role will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes. Ideal...
- ...leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...products. The candidate will prepare regulatory submissions, interact with health authorities like the FDA, and ensure compliance...
$294k - $318k
Department: 1310US - Regulatory - USLocation: Waltham... ...program through functional managers and leaders, setting... ...preparation and submission of major regulatory filings... ...related to clinical, nonclinical, and CMC development... ...including regulatory writing, cross-functional...Local area- ...a senior toxicology leader to design, oversee, and interpret nonclinical safety programs across all phases of drug development in Watertown... ...discovery, and program teams, draft CTD sections for IND/NDA submissions, and represent toxicology in cross-functional leadership...
$143k - $233k
...position will play a key role in regulatory strategy development and... ...and execute CMC global submission plans and timelines in accordance... ...affairs and/or program management, as applicable.Lead and manage... ...proactive.Strong technical writing and document review skills.Excellent...$157k - $173k
.... Position Summary: The Senior Manager, Regulatory Affairs will support the development... ...will contribute to global regulatory submissions, health authority interactions, and cross... ...global regulatory strategies across nonclinical, clinical, CMC, and device components...Local area$196.7k - $353.4k
...is seeking a Sr. Director of Regulatory Strategy to support oncology... ...for regulatory submissions and related supplements and... ...strategy through the clinical and nonclinical development processes. Identifies... ...additional data, organizes and manages participation in meetings....Permanent employmentFull timeWork at officeWork from home- ...is seeking an experienced and strategic regulatory leader to join a growing biotechnology... ...regulatory guidance on development plans, submission strategies, and regulatory pathways.... ...closely with Clinical Development, CMC, Nonclinical, Quality, and other cross-functional...
$195k - $330k
...an impact:Act as the global regulatory strategy lead for Kymera’s IRF... ...closely with Clinical, CMC, Nonclinical, Quality, and Commercial... ...teams and senior leadership.Manage and support junior regulatory... ...least one marketing application submission and approvalDemonstrated...Flexible hours- ...Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...the development of robust and accurate submissions. Develops constructive relationships... ...some supervision, plans, executes and manages regulatory submissions according to the...
$275k - $315k
...and experienced Senior Director of Regulatory Affairs to lead and execute US... ...and execution—from IND through BLA submission and approval. You will manage a small team of Regulatory Affairs... ...cross-functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations...Full timeTemporary workWork at officeLocal area3 days per week$120k - $140k
...for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (... ...submissions is required with the ability to successfully manage projects to deadlines. A working knowledge of electronic publishing...Work at office$215k - $235k
...Role: The Director of Regulatory Affairs is responsible... ...strategy into actionable submissions, briefing materials,... ...with clinical, nonclinical, and CMC development plans... ...designation requests.Manage submission, agency correspondence... ...coordinate medical writing support and submission...$171.2k - $256.8k
...oversight across clinical and nonclinical programs to ensure compliance with GCP, GLP, and global regulatory requirements. This role... ...execution, vendor and CRO quality management, inspection readiness,... ...regulatory inspections and submissions, and provide strategic QA guidance...Contract work- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations... ...of eCTD requirements for submission to US and ex-US regulatory... ...communicate verbally and in writing, and superb organizational skills required.* Ability to manage multiple priorities within a...Contract workRemote work
$238k - $374k
...DescriptionExecutive Director, Global Regulatory Affairs CMC Early... ...CMC regulatory strategies and submissions for small molecule and... ...predictive tools, data and knowledge management, and digital CMC dossiers)... ..., Development, Clinical, Nonclinical, Quality, Safety, Manufacturing...Minimum wageTemporary workLocal areaRemote work$238k - $374k
...Executive Director, Global Regulatory Affairs CMC Devices and Drug... ...regulatory strategy and major submissions for an assigned portfolio of... .../human factors, risk management, and value messaging to regulatory... ...interprets complex technical, nonclinical, clinical, and manufacturing...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$170.9k - $231.3k
Overview The Associate Director of Regulatory Affairs Strategy will serve... ...strategy and facilitate submission of data packages to the US.... ...include involvement in the writing and oversight of regulatory... ...and with regulatory program managers at HAs. Maintain regulatory...Full timeTemporary workLocal areaFlexible hours$190k - $210k
...Role Associate Director, Global Regulatory Affairs, Compliance As the... ...guidance. You will support the management and compliance of high‑quality regulatory submissions—including INDs, NDAs, health authority... ...the regulatory and technical writing required throughout the product...Work at officeFlexible hours2 days per week$89.8k - $170.5k
...you and that’s why there’s nowhere like RSM.RSM is looking for a Manager to join our Consumer Products Assurance team. You will have the... ...(日本語) or Mandarin(普通话) to include but not limited to speaking, writing and reading with a deep understanding of the culture and...Full timeWork experience placementInternshipLocal area$120k - $150k
Job Summary:The Assurance Experienced Manager is responsible for supervising, directing,... ...advising the client on various economic and regulatory risks within their industry, resolving... ...consistently within complex situations, writing technical consultation memos on GAAP /...Work at office- The Director of Regulatory Affairs provides strategic and... ...prepare regulatory submissions of regulatory applications... .... Organize and manage meetings with Health Authority... ...final clinical and nonclinical study reports, and... ...development-related documents. Write regulatory documents...
- Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global... ...other clinical studies. This role includes driving global submission planning, coordination, and execution across multiple regions...Full timeRemote work
$170k - $240k
Litigation Marketing Senior Manager - RegulatoryCooley is seeking a Litigation Marketing Senior Manager - Regulatory to join the Marketing and Client Development team.Position... ...: Direct the narrative strategy and submission process for legal directories and rankings...Full timeTemporary workWork at officeImmediate startFlexible hoursWeekend work$245k - $300k
...Description: Sr. Director, Regulatory Affairs At Merida Biosciences... ...with Program Leadership & Management, Clinical Development,... ...Biostatistics, Pharmacovigilance, CMC, Nonclinical, Quality, and Executive... ...on regulatory pathways, submission strategies, expedited programs...Local area
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