NDA Submissions & Regulatory Strategy Lead
Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is seeking a Director of Regulatory Affairs to lead regulatory strategy, manage NDA filings, and oversee external publishing and consulting partners within a lean, virtual sponsor model. The RA Director will develop and execute submission strategies, coordinate reviews, maintain regulatory records, and drive cross-functional collaboration to support clinical development and lifecycle management of multiple programs. #J-18808-Ljbffr
- ...Fate Therapeutics, Inc. is seeking a Senior Manager, Regulatory Affairs CMC to shape global CMC regulatory strategy and lead submissions for cell therapy products. The role collaborates across technical and quality teams to support licensure and lifecycle management....Regulatory
- ...Neurocrine Biosciences seeks an experienced Regulatory Affairs leader to provide project leadership for regulatory submissions and process development. You will work with... ...coordinating IND/CTA activities, shaping global strategies, and mentoring less experienced colleagues....Regulatory
- ...medical writing for complex clinical and regulatory documents. You will lead authoring and end-to-end development for health authority submissions. Requirements include a PhD preferred, 5... ...experience, and strong knowledge of NDA/eCTD modules. Collaboration across cross...Regulatory
- ...Arrowhead Pharmaceuticals, Inc. is seeking a dynamic Regulatory Affairs professional to support multiple global regulatory projects... ...Affairs and work with cross‑functional teams to align strategies and submissions. The role focuses on IND/CTA/IMPD filings, health authority...Regulatory
- ...Becton, Dickinson and Company is seeking a Program Manager to lead regulatory readiness for technical documentation across in-market... ...D, Quality, and other functions to ensure timely, compliant submissions and re-registrations. The role requires strong program management...Regulatory
- ...Neurocrine Biosciences is seeking an Executive Director of Regulatory Strategy for Endocrinology to shape global regulatory plans from early development through commercialization. You will lead a three-person team and partner with Clinical Development, Safety, Commercial...Regulatory
$185.5k - $251k
...Job Overview Come join Intuit as a Lead, SOX Program Strategy & Audit Excellence - ITGC/ITAC within the SOX Risk and Compliance Organization... ...operationalized across the SRCO team. Monitor the evolving regulatory environment (PCAOB, SEC) and incorporate relevant changes...RegulatoryWork experience placementWork at office- ...clients. You will guide clinical development strategies, ensure scientific excellence, and shape data analyses throughout regulatory submissions and approvals. The role requires a deep regulatory background, a passion for leading teams, and a track record of influencing...Regulatory
- ...Iambic Therapeutics is seeking a Principal Medical Writer to independently author and oversee submission-ready documents supporting clinical-stage programs and IND submissions. Reporting to the Head of Medical Writing, this role will partner with cross-functional stakeholders...Regulatory
- ...Executive Director, Regulatory Strategy About the Company Clinical-stage... ...the regulatory face of its lead program, which is in the... ...organization to support various global submissions. This is a unique... ...particularly in the context of NDA, MAA, and other international...Regulatory
$116k - $151k
...vision of becoming a leading biopharmaceutical company... ...Summary:The Manager, Regulatory Affairs provides... ...of global regulatory strategies from development through... ...regulatory planning, submission execution, Health Authority... ...application components (e.g., NDA, BLA, MAA).Lead...RegulatoryFull timeContract workTemporary workRemote work- ...BD in the United States seeks a Regulatory Affairs professional to lead regulatory submissions for medical devices across the US, Europe, and other markets. You will develop regulatory strategies and manage submissions to ensure lifecycle compliance across V&V, risk management...Regulatory
- ...Fate Therapeutics, Inc. is seeking a Senior Manager, Regulatory Affairs CMC to shape global CMC regulatory strategy and lead high‑quality submissions for cell therapy products. This role collaborates across technical and quality teams to support development through licensure...Regulatory
$258.68k - $313.46k
...of those who do it.Sr Director, Global Regulatory Strategy, NeuroscienceWill be a key member of... ...regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned... ...with the regulatory product managers (submissions) and regulatory operations group, for...RegulatoryHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours- ...About Freyr Freyr Inc. is a leading global Regulatory Solutions and Services company, supporting large... .... The position will lead labeling strategy across development and marketed... ...to meet internal and Health Authority submission timelines. Manage and facilitate review...RegulatoryPermanent employmentRemote work
- ...biopharmaceutical firm is seeking a Head of Quality to lead and scale their quality operations from... ...Quality Assurance with proven success in NDA preparation. The ideal candidate will... ...collaborate across functions, ensuring regulatory compliance and readiness for product...Regulatory
$109k - $174.8k
...finding treatments and cures. We lead where medicine is going and... ...for planning, programming strategy, coordination, oversight, and... ...reporting activities. Supports submission activities including but not... ...preferred. Working knowledge of regulatory guidelines (e.g. ICH-GCP) and...RegulatoryLocal areaImmediate start$132.7k - $182k
...Responsibilities Develop, review, and file regulatory submissions including INDs, CTAs, DSURs, and... ...Collaborate on global regulatory strategies supporting CMC, nonclinical, and clinical... ...consent forms, and recruitment materials Lead and coordinate preparation of...Regulatory- ...Associate Director, Labeling Strategy is responsible for developing and executing global regulatory labeling strategies throughout... ...This role serves as the labeling lead for assigned development and... ...development programs, regulatory submissions, and post-marketing activities...RegulatoryLocal areaRemote work
$230.9k - $384.8k
...Pfizer seeks a Medical Channel Strategy and Engagement Lead to develop and execute omnichannel digital engagement strategies across therapeutic... ...dissemination, and media channel management while ensuring regulatory compliance. Responsibilities Lead team to design...RegulatoryLocal area$187.2k - $255k
...Neurocrine Biosciences seeks a Director of Regulatory Strategy to lead regulatory activities for development... ...regulatory strategy, preparing submissions to health authorities, collaborating... ...regulatory strategy and oversee IND/CTA/NDA/MAA submission preparation and...Regulatory- ...is seeking an Associate Director, Medical Writing to lead writing efforts for clinical and regulatory documents. Reporting to the Senior Director, Medical... ...writers. A strong background in oncology writing and a track record of high-quality submissions is #J-18808-LjbffrRegulatory
- ...Develop and execute global regulatory labeling strategies throughout the product lifecycle Serve as labeling lead for assigned development and commercial products Lead Labeling... ...functions for timely Health Authority submissions and label negotiations Interpret...RegulatoryLocal area
$185k - $300k
...this role:Wells Fargo is seeking a Senior Lead Treasury Management Consultant as a part... ...US centric Sales teams and lead client strategy discussions. This role must be able to... ...Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively...RegulatoryFull timeWork experience placementWork at officeRemote work- ...shape the US National Field Medical Team strategy and oversee a regional MSL network. You will... ...for the metabolic portfolio. You will lead a team of health professionals, manage resources, and ensure compliance with regulatory standards while traveling as needed to build...RegulatoryRemote work
$160k - $250k
...This plays a key role in growth strategy and business development for... ..., and emerging markets.Lead business development effort through... ..., engineering, and regulatory service lines.Review and approve... ...reports, plans, and regulatory submissions.Prepare and review expert reports...RegulatoryFull timeWork at office$150k - $195k
...Department: 107000 Regulatory Location: San Diego, USA- Remote Be... ...pursue our vision of becoming a leading biopharmaceutical company... ...Associate Director, Labeling Strategy is responsible for developing... ...programs, regulatory submissions, and post‑marketing activities...RegulatoryTemporary workLocal areaRemote work- ...execute integrated corporate and product communications strategies. This individual contributor role leads agency partners and cross-functional workstreams to... ..., and publications, mentor colleagues, and ensure messaging aligns with regulatory requirements. #J-18808-Ljbffr...Regulatory
$150k - $190k
...execute Orbital’s regional commercialization strategy, tailoring the global playbook to the... ...of the US market, buying behaviors, and regulatory environments.· Identify and prioritize... ...strategic opportunities and major pitches.· Leading internal demonstrations, enablement...RegulatoryLocal area- ...Planet Pharma seeks a Project Manager to lead cross-functional initiatives focused on technical dossier audits and regulatory readiness for in-market clinical diagnostic... ...documentation for global registrations and submissions. The role coordinates systematic reviews of...Regulatory
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