Remote Regulatory Affairs Manager — FDA Submissions Leader
Collabera
- Remote job
A leading IT staffing firm is seeking a Regulatory Affairs Manager for a remote opportunity. The role involves ensuring compliance with FDA regulations, leading regulatory submission processes including 510(k)s, and developing regulatory strategies for product development. Candidates need a Bachelor’s degree, 5+ years of experience in medical device regulatory affairs, and strong leadership skills. This position plays a critical role in supporting business growth and ensuring regulatory compliance. #J-18808-Ljbffr Collabera
- A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global regulations. The ideal candidate has 5-10 years of experience in Regulatory CMC, a strong technical background in relatorette...Remote job
$110k - $150k
...actionable insights, is building a regulatory team to develop regulated medical devices and seek FDA marketing authorization. The Manager of Regulatory Affairs will work closely with scientists... ...objectives. Lead and assist with submissions and correspondence with global...Remote job- Avance Clinical is seeking a Chief Commercial Officer (CCO) to lead market expansion and drive business development. You will be an integral part of the executive leadership team, reporting directly to the CEO, and responsible for crafting the commercial strategy in the...Remote work
- A startup accelerator is seeking an ambitious SaaS Co-Founder/CCO to lead the development of a startup. This 100% remote role offers funding options and access to a network of successful entrepreneurs. Key responsibilities include building a scalable startup and receiving...Remote job
- A healthcare firm is seeking a Head of Regulatory Affairs for a permanent, full-time position based in the United Kingdom. The role requires... ...candidate will deliver regulatory strategies, ensure compliance, and manage a high-performing team. Strong knowledge of ICH-GCP and...Remote jobPermanent employmentFull time
- ...Pharma in California is seeking a Regulatory CMC professional to lead the... ...for IND, NDA, and MAA submissions. The role requires extensive experience in regulatory affairs within biotechnology and a strong... ...hybrid work model, combining remote work with periodic office...Remote jobWork at office
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco,... ...drug approvals and submissions. Candidates should... ...in Regulatory Affairs CMC within the biotech... ...industry and be adept at managing complex global submissions... ...position is hybrid, with remote work and occasional...Remote job- A leading staffing firm is seeking a Regulatory Affairs Manager for a 6-month contract in Wayne, PA. The role involves managing regulatory activities... ...US requirements, ensuring compliance, and coordinating submissions for products. Ideal candidates will have a BA/B.S in a...Contract work
- Join Parachute in Austin is seeking a Manager, Regulatory Affairs to lead daily operations, manage FDA submissions, and mentor the regulatory team. The ideal candidate will have over 5 years of experience in Regulatory Affairs within a regulated life sciences environment...
- ...staffing firm in Massachusetts is seeking an experienced Regulatory Affairs Manager to ensure compliance with FDA and other regulations for medical devices. This... ...affairs, including experience with 510(k) submissions and interaction with FDA. The candidate should possess...Permanent employment
- Monte Rosa Therapeutics, Inc is seeking an experienced regulatory affairs professional in Boston, MA. Responsibilities include coordinating regulatory workflows, compiling submissions to the FDA, and providing ongoing support to project teams. The ideal candidate holds...
- ...biopharmaceutical company in Carmel, Indiana, is seeking a Regulatory Affairs professional to support global regulatory CMC activities. This role involves collaborating on submissions for clinical programs and managing CMC regulatory strategies. The ideal candidate will...
- ...experience and will be expected to partner with leadership on crucial legal negotiations while designing scalable systems across the organization. The position offers a competitive salary and comprehensive benefits in a remote-first workplace. #J-18808-Ljbffr Whistler PartnersRemote work
- ...biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory... ...documents, and ensuring compliance with FDA regulations. Candidates should have a...Work at office
- ...Providing strategic direction for product and disease communications, the full-time remote Regulatory Affairs Senior Manager will ensure compliance with FDA regulations, evaluate promotional materials, and mentor team members in a dynamic regulatory environment. Key responsibilities...Remote workFull time
- ...Access & Inclusion. This position is vital for overseeing financial management of grants to legal aid organizations, ensuring compliance, and... ...with at least one in a leadership role. The position allows four days of remote work weekly. #J-18808-Ljbffr State Bar of CaliforniaRemote jobWork at office
- ...from GForce Life Sciences Senior Regulatory Affairs Manager 12-month Contract, Remote Must be able to work on a W2 Requirements... .... Lead clinical and nonclinical FDA interactions in alignment with... ...development programs. Regulatory Submissions and Related Activities Ensure...Remote workContract work
- Daiichi Sankyo in Basking Ridge, New Jersey, is seeking a Manager for Regulatory Affairs - CMC. The role involves managing developmental and post marketing projects, preparing submission documents, and leading FDA interactions under supervision. The ideal candidate will...
$174.5k - $274.23k
...maximize global regulatory success towards achievement... .... Is a leader both in the department... ...colleagues, line management, and key... ...Accountable for all US FDA submissions and approvals of... ...within regulatory affairs and implications... ...Takeda’s Hybrid and Remote Work policy....Remote workMinimum wageFull timeTemporary workLocal area- ...with a market leader that continues... ...position can be a remote working... ...role develops regulatory strategies for... ...products. This role manages and submits 510... ...communications with FDA including pre-... ...manages regulatory submissions, including 510(... ...Regulatory Affairs professionals,...Remote workWork at officeWorldwideHome office
$176.4k - $207.5k
Recursion is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategies... ...will collaborate across teams, manage complex projects, and ensure compliance... ...regulatory requirements. The position is remote-friendly, with a salary range of $176,4...Remote work- ...leading life sciences company is seeking a Regulatory Operations Manager to oversee the publishing of deliverables for electronic submissions to health authorities. The role involves... ...in the US and Europe. This is a remote position requiring expertise in compliance...Remote job
- GSK is looking for a professional in regulatory affairs to lead the planning and delivery of regulatory submission dossiers. The role involves collaboration with various... ...for both in-office collaboration and focused remote work. Candidates should have at least 3 years...Remote workWork at office
$100k - $110k
...an alternative application process. Regulatory Affairs Manager Full Time Headquarter, Westport, CT... ...registrations, including FDA 510(k) submissions and ex-U.S. market registrations. The... ...Standard office environment and/or remote work. Physical Demands The physical...Remote workFull timeWork at office$221k - $286k
...Pharma is seeking a Senior Director of Regulatory CMC in Oceanside, CA, to provide... ...includes overseeing global CMC strategies, submissions, and managing workforce talent. Candidates must... ...This position offers flexible work with remote options. #J-18808-Ljbffr Kite PharmaRemote workFlexible hours- A biotechnology company is seeking a Senior Specialist for Regulatory Operations to manage regulatory submissions and support systems in Frederick, MD. This role requires 3-4 years of relevant experience in the biotech or pharmaceutical industry, along with a strong understanding...Remote job
- ...with the CEO and board. The ideal candidate has extensive experience with CFTC compliance, DCM and DCO operations, and a strong regulatory background. This position offers an opportunity to make a significant impact in a fast-paced environment focused on growth and compliance...Remote job
- Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and... ...stock incentives, and generous PTO. This position offers a remote work option with travel as needed. #J-18808-Ljbffr Praxis...Remote job
- Women In Bio seeks a Regulatory Affairs Specialist to lead the planning and delivery of regulatory submission dossiers in the United States. You will collaborate with teams across... ...allows for both in-office teamwork and remote focused work days. #J-18808-Ljbffr Women In...Remote workWork at office
$70k - $130k
...biotechnology company is seeking a Senior Specialist in Regulatory Operations to manage regulatory submissions across their development pipeline. The role involves... ...s degree in a scientific field. The position can be remote or based at the company's office in New Jersey,...Remote jobWork at office
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