Senior Medical Writer - Regulatory Submissions Lead
Sobi
Sobi in San Diego is seeking a Principal Medical Writer who will lead the authoring of clinical and regulatory documents. This role requires 8-10 years of experience, focusing on clarity and credibility in submissions to fulfill regulatory needs. The ideal candidate will have a Life Science Master’s degree or PhD, alongside strong analytical and communication skills. The position offers a competitive salary range of $160,000 - $200,000 annually with bonus eligibility. #J-18808-Ljbffr Sobi
- ...San Diego is looking for an Associate Director, Medical Writing to oversee regulatory submissions and manage related documentation. This role... ...PharmD is preferred. The Associate Director will lead a team of medical writers, ensuring high-quality deliverables are completed...SeniorRegulatoryRemote job
$132k - $172k
Travere Therapeutics in San Diego is seeking a Senior Manager, Medical Writing to oversee the authoring and management of regulatory, clinical, and safety documents. This role requires leadership in document strategy and adherence to compliance while working closely with...SeniorRegulatory- ...qualified and experienced Senior Medical Writer to join our team. The ideal... ...scientifically accurate, and regulatory-compliant documents. This... ...Responsibilities: Lead the development of clinical... ...brochures, and regulatory submission documents. Ensure all documents...SeniorRegulatoryWork at office
- Role, Inc. is seeking a Senior Manager for CMC Regulatory Affairs in San Diego, focusing on global regulatory strategies to support biologics development... ...focus on late-stage development programs and regulatory submissions. The position is hybrid, allowing for both remote and on...SeniorRegulatoryRemote job
- ...looking for an experienced Medical Writer to assist our clients... ...brochures, dossiers, regulatory filings, and other... ...RegDev is looking for a Senior Medical Writer... ...development and regulatory submissions to global health authorities... ...team comments and lead meetings. Interpret medical...SeniorRegulatoryWork at officeHome officeShift work
- ...define the scientific strategy for Drug Metabolism & Pharmacokinetics. The role involves managing DMPK strategies, overseeing regulatory submissions, and collaborating with cross-functional teams. Candidates should have a PhD or PharmD, along with 12+ years in the...SeniorRegulatory
- CorDx is seeking a Senior Regulatory Affairs Manager to oversee regulatory submissions for medical device products. This role requires a Master's degree and 7-10 years of experience in regulatory affairs, specifically within the medical device industry. The Manager will...SeniorRegulatory
$220.6k - $275.7k
Acadia Pharmaceuticals is seeking a Senior Director of Regulatory Operations, based in San Diego, CA.... ...operations and overseeing electronic submissions. The ideal candidate will possess strong... ...with various benefits including medical insurance and a 401(k) plan. #J-188...SeniorRegulatory- MillenniumSoft Inc is seeking a Senior Technical Writer in San Diego, CA, for a 12+ month contract... ...and collaborate with engineering and regulatory teams to ensure compliance in product... ...regulated industries like pharmaceuticals or medical devices and have a robust...SeniorRegulatoryContract workWork at office
$132.7k - $182k
Neurocrine Biosciences is seeking a CMC Regulatory Affairs Manager in San Diego, California. This role involves overseeing regulatory activities for development and marketed projects, managing submissions, and ensuring compliance with government regulations. The ideal...Regulatory$132.7k - $182k
Neurocrine Biosciences is seeking an experienced professional in Regulatory Affairs based in San Diego, California. This role involves... ...regulatory strategy execution and preparing regulatory submissions including IND/CTA, NDA/BLA, and clinical research documentation...Regulatory- RegDev, Inc. is seeking an experienced Medical Writer Consultant to assist in authoring clinical protocols and regulatory filings. This position demands expertise in translating complex clinical data into clear, compliant documents for drug development. Ideal candidates...SeniorRegulatoryRemote work
- ...their Microbiology lab in San Diego, CA. This role coordinates laboratory activities, manages a team, and ensures compliance with regulatory requirements. The ideal candidate will have a Bachelor’s in Life Sciences and at least five years of experience in Microbiology,...SeniorRegulatory
- ...Therapeutics Inc. is seeking an Associate Director, Biologics CMC, to support biologics development from upstream cell culture to regulatory submissions. The role offers a unique opportunity to influence large molecule programs. With responsibilities including technical...SeniorRegulatory
- Neurocrine Biosciences in San Diego is seeking a Regulatory Affairs professional to lead the review of medical education and promotional materials. This role involves ensuring compliance with FDA regulations while assessing regulatory risks related to promotional strategies...SeniorRegulatory
- Role, Inc. is seeking a Senior Manager, Medical Writing in San Diego. This position is responsible for authoring and managing regulatory documents, ensuring scientific accuracy and compliance while collaborating with cross-functional teams. The ideal candidate will have...SeniorRegulatory
- Danaher Corporation, via Leica Biosystems, seeks a Senior Counsel to serve as the lead legal advisor for multiple business units, supporting R&D,... ...on complex commercial and corporate transactions, IP, regulatory, M&A, and governance, partnering with external counsel....SeniorRegulatoryRemote job
$160k - $200k
...Overview As a Principal Medical Writer, you will provide communication expertise and lead a strategy‑driven approach... ...key clinical and regulatory documents and regulatory submissions, ensuring clarity, credibility... ...documents. Liaise with senior project staff, prospectively...RegulatoryOdd jobFlexible hours$160k - $200k
...Description As a Principal Medical Writer, you will provide communication expertise and lead a strategy‑driven... ...authoring key clinical and regulatory documents and regulatory submissions, ensuring clarity, credibility... ...documents. Liaise with senior project staff,...RegulatoryOdd jobTemporary workFlexible hours$160k - $200k
...Description As a Principal Medical Writer, you will provide communication expertise and lead a strategy-driven... ...authoring of key clinical and regulatory documents and regulatory submissions, to ensure clarity,... ...documents. Liaise with senior project staff, prospectively...RegulatoryOdd jobTemporary workWork at officeFlexible hours- ..., influencer partnerships, patient ambassador programs, and online communities to educate, engage, and build trust while meeting regulatory expectations. The role partners across Consumer Marketing, Clinical, Product, and Customer Care to translate launches and milestones...SeniorRegulatory
- ...Compliance Specialist (Specialist 3). BD is one of the largest global medical technology companies in the world and is advancing the world... ...California. This program exclusively s... Show more Deloitte Regulatory, Risk & Forensic Team Our Deloitte Regulatory, Risk & Forensic...SeniorRegulatoryWeekly pay
$140k - $190k
...Description Pay Range - $140k-190k Position Summary The Lead Policy Writer owns the compliance documentation function at Correctional... ...— the infrastructure that gives the organization its regulatory backbone across a growing multi-state correctional healthcare...RegulatoryFull timeWork at officeRemote workMonday to Friday$119k - $156k
...openness. We are seeking an experienced Senior Lead, Enterprise Master Data who will play a... ...13485), supporting audit readiness and regulatory requirements Standardize customer... ...Business Systems (biotech, pharma, or medical device experience preferred) Strong working...SeniorRegulatoryFull timeFlexible hours- Role, Inc. is looking for a Manager of Medical Writing Operations in San Diego to lead the development of regulatory and clinical documents. This position requires advanced... ...quality, manage timelines, and contribute to submission-ready deliverables. Benefits include...Regulatory
- ...Irvine Company is seeking a Senior Director, Project Management, to lead the San Diego regional team in overseeing property damage repair and reconstruction... ...through project efficiency, quality control, and regulatory compliance. The ideal candidate will have significant...SeniorRegulatory
- Qualcomm is seeking an experienced Product Security Engineer to lead product security lifecycle efforts. You will ensure compliance... ...candidate has extensive experience in product security, strong regulatory compliance knowledge, and the capability to mentor others. Salary...SeniorRegulatory
- ...to oversee environmental compliance and hazardous waste management. The role includes developing programs, ensuring adherence to regulatory standards, and providing technical guidance across departments. The successful candidate will have a BS/BA in a relevant discipline...SeniorRegulatory
- Intuit is looking for a Principal Regulatory Compliance Manager in San Diego, California. This hybrid role involves overseeing U.S. money transmission compliance and requires at least 8 years of relevant experience. You will guide cross-functional teams, manage compliance...SeniorRegulatory
- Pacira BioSciences, Inc. is seeking a Senior Manager in Biostatistics who will lead statistical activities for multiple clinical development programs. The... ...trial designs and analyses, with strong knowledge of regulatory guidelines. #J-18808-Ljbffr Pacira BioSciences, Inc.SeniorRegulatory
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