Director, Biologics CMC Regulatory Writing
Travere Therapeutics
Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of regulatory CMC documentation, including BLA submissions. You will drive the strategy with Regulatory Affairs and SMEs, delivering rigorous, regulator-ready content that communicates development history, manufacturing process, control strategy, and commercial readiness.
The ideal candidate has extensive experience authoring Module 3 content for biologics, strong scientific
#J-18808-Ljbffr$189k - $246k
...service for rare patients. Position Summary The Director, Technical Operations (Biologics CMC Technical Writing) is responsible for the preparation of Chemistry... ..., and Controls (CMC) documentation for regulatory submissions, including Biologics License Application...RegulatoryContract workTemporary workWork experience placementRemote work- ...Senior Director, Biologics CMC (4 days onsite, 1 day remote) Position Summary Reporting to the Head of CMC, the Senior Director, Biologics... ...manufacturing, analytical development, quality, regulatory CMC, and external manufacturing. Because we are a lean...RegulatoryFull timeRemote work
$169.1k - $212.8k
...more about our company and culture! Site: The Associate Director, Regulatory Affairs - CMC will be responsible for leading global regulatory CMC... ...cross functional teams and key stakeholders. Works with CMC Writing, Regulatory Operations, and Submission Project...RegulatoryTemporary workWork at office- Scorpion Therapeutics seeks a Senior Manager, CMC Regulatory Affairs to lead regulatory strategy for biologic drug development and lifecycle management. You will drive global CMC submissions and health authority interactions, enabling late-stage programs and rare indications...RegulatoryRemote job
- ...Operations organization, leading CMC strategy, manufacturing, product development, regulatory execution, and... ...execution. Lead integrated biologics and radiopharmaceutical CMC regulatory... ...Executive Leadership, the Board of Directors, and external stakeholders....RegulatoryFull time
$173.2k - $272.6k
## Director, Biologics Development and Commercialization Team Lead (CMC Team Lead)Apply: Hybrid: USA - Pennsylvania - West Point:... ...impact technical, operational & regulatory success or timelines. Analyzes... ..., Technology Transfer, Writing Technical Documents**Preferred...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hours- ...offering expertise in regulatory strategy, clinical trial... ...Overview The Director, Regulatory Affairs will... ...regulatory discipline (e.g., CMC); MS or PhD preferred.... ...(HCT/Ps, drugs and/or biologics, medical devices, and... ...medical/technical writing, and verbal...RegulatoryWork experience placement
$193.63k - $254.14k
...myeloma. Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team... ...Regulatory CMC experience supporting biologics, cell and gene therapy. Direct... ...thinking, communication, and technical writing skills. Ability to manage multiple programs...RegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...Job TitleIndustry Regulatory AffairsJob DescriptionThis position in CMC Regulatory Affairs involves the ability to support and provide some management to guide... ...submissions.• Assist with the planning, scientific writing and perform critical reviews of a pre-INDs, INDs, IMPDs...Regulatory
- Pathos is seeking a Director of CMC - Small Molecule Chemistry to lead the chemistry, manufacturing, and controls strategy for our oncology... ...-stage development, ensuring quality, robust processes, and regulatory-ready documentation. This foundational role partners with...Regulatory
- Travere Therapeutics is seeking a Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing activities. The role emphasizes... ...API programs with global CDMO oversight and regulatory documentation leadership. Remote with 10-20% travel;...RegulatoryRemote job
- ...Scorpion Therapeutics is seeking an Associate Director, Technical Operations specializing in analytical development for biologics in a rare disease biopharma setting. You... ...root cause investigations, and contributing to regulatory submissions in a global #J-18808-LjbffrRegulatoryRemote work
$210k - $250k
Director, CMC - Small Molecule Chemistry Drug development shouldn’t be guesswork, not when patients are waiting. Pathos is building a next... ...— ensuring phase-appropriate quality, robust processes, and regulatory-ready documentation. This is a foundational hire on the...RegulatoryWork at office3 days per week- ...seeking an experienced and dynamic Director or Associate Director of Regulatory Affairs that will be responsible for... ..., submission requitements and writing for pharmaceutical products targeted... ...requirements for preclinical, clinical, and CMC submissions. Exceptional project...RegulatoryRemote work
- ...Scorpion Therapeutics is seeking a Senior CMC Director to lead the development and execution of CMC strategies for small molecule programs... ...process validation, and cGMP manufacturing, while reviewing regulatory filings and ensuring compliance. You will provide technical...RegulatoryRemote work
- ...chemistry manufacturing and controls (CMC) consultant with expertise in... ...connection with the preparation of biologics and synthetic drug regulatory applications for submission to FDA and... ...Candidates will have strong dossier writing experience and be able to manage challenging...RegulatoryFor subcontractor
- Legend Biotech US is seeking a Director, Regulatory CMC based in Somerset, NJ, to lead global CMC regulatory strategies for late-stage and post-approval programs within Regulatory Affairs. You will influence development and manufacturing strategies and serve as the primary...Regulatory
$163.47k - $214.55k
...of multiple myeloma. Legend Biotech is seeking an Associate Director, CMC Project Management as part of the Technical Development team... ...process development, analytical development, operations, quality, regulatory) ensuring alignment with line functions and across strategic/...RegulatoryPermanent employmentFull timeContract workTemporary workLocal areaWorldwideFlexible hoursShift work- ...We’re Hiring: Senior Director, Biostatistics - REMOTE We are partnering with a clinical... ...assets through key development and regulatory milestones. The requirements for this role... ...Management, Statistical Programming, Medical Writing, Regulatory Affairs, and...RegulatoryFull timeInterim roleRemote work
- ...The Director of Giant Steps provides strategic, clinical, and operational leadership for... ...planning) meet professional, ethical, and regulatory standards. Ensures clinical integrity... ...clearly in English, both orally and in writing Ability to lead and manage a multidisciplinary...RegulatoryFull timeMonday to FridayFlexible hoursAfternoon shift
- ...company focused on discovering and developing next-generation biologic therapeutics for chronic respiratory and immunological... ...Protein Engineering, AI Drug Design, Translational Sciences, CMC, Toxicology, Regulatory, and Clinical Development teams to deliver integrated...RegulatoryRemote workWorldwide
$130k - $140k
...Director, Government Grants Location: New York, NY Schedule: Full-Time, 40 hours per week FLSA: Exempt Salary... ...priorities, programmatic needs, and emerging policy or regulatory trends. Proposal Writing Lead the development, writing, and submission of...RegulatoryFull timeWork at officeLocal area$169.22k - $253k
...The Associate Director, Drug Product & Process Development, will provide... ...strategy development, regulatory filings, and post‑approval lifecycle... ...role will serve as a key CMC contributor to cross‑... ...changes. Excellent technical writing, communication, and cross‑functional...RegulatoryTemporary workLocal areaWorldwideFlexible hours- ...and strengthening WuXi's brand across complex, multi-stakeholder CMC programs. While WuXi brings deep technical expertise across its... ...with diverse client stakeholders across R&D, CMC, Quality, Regulatory, and Procurement. Establish WuXi as a reliable, transparent, and...RegulatoryRemote workWork from home
- ...Title: Director, Senior Legal Counsel, Structured Finance Group Requisition ID: 2604... ...Supports the development, structuring, regulatory analysis, of new products and business initiatives... ...skills. ~ Excellent judgement, writing skills, and presence. ~ Self-starter,...RegulatoryLocal areaFlexible hours
$250k - $325k
...QualificationsAs a Commercial Disputes Advisory Senior Director, you will:Lead and supervise day-to-day... ...legal teams, corporate executives, and regulatory agenciesBuild and maintain strong client... ...and PowerPointAbove average business writing and communication skillsAbility to...RegulatoryFull timeImmediate start- ...Alliance for Public Charter Schools seeks a Director, Policy to advance federal policy... ...national policy. Responsibilities include regulatory engagement, program development, and stakeholder... ...years in policy work, with exceptional writing and communication skills and the ability...Regulatory
$265k - $300k
Senior Scientific Director, Neurodegenerative DiseasesAre you ready to accelerate your potential... ...vitro diagnostic product development, regulatory pathways such as United States Food and... ...supporting diagnostic claims.Scientific writing and communication strength sufficient to...RegulatoryHourly payFull timeWork at officeRemote workWork from homeWorldwideFlexible hoursNight shift$165k - $195k
...with us on LinkedIn. About the Role:The Director / Senior Director, Science plays an integral... ...and publication record who is eager to write, speak, and publish externally to... ...Work closely with product, clinical, and regulatory teams to ensure that product development...RegulatoryPermanent employmentTemporary workWork at officeLocal areaRemote workVisa sponsorshipFlexible hours$175k - $200k
...Director of Underwriting & Asset Management Paragon Capital Group Remote (US) or hybrid... ...Transaction coordination: project-level regulatory filings required before a new raise,... ...and closing transactions • A record of writing credit analysis for decision-makers and...RegulatoryRemote workRelocation
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