Regulatory Submissions Lead (Remote EST)
GForce Life Sciences
A 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 vendor oversight, quality control of submission-related documents, and ensuring compliance with submission standards and regulations. Candidates should have 3-5 years of regulatory operations experience, particularly in the US and Europe. This is a remote position requiring expertise in compliance and submission guidelines. #J-18808-Ljbffr
$80 - $90 per hour
Eightelevengroup is looking for a Lead Medical Writer based in Eastern Standard Time (EST) for a 2-month remote contract. The role involves autonomously... ...writing and reviewing clinical regulatory documents, contributing to submission teams, and mentoring junior writers...Remote jobRegulatoryHourly payContract work- ...Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international... ...match, stock incentives, and generous PTO. This position offers a remote work option with travel as needed. #J-18808-Ljbffr...Remote workRegulatory
$128k - $156k
Disc Medicine in Watertown, MA, is seeking a Regulatory Operations Manager to manage regulatory submissions and document compliance activities. This full-time role requires 5-7 years of direct experience and expertise in MS Word and Veeva RIM. Responsibilities include...Remote jobRegulatoryFull time- ...biotechnology company is seeking a Senior Specialist for Regulatory Operations to manage regulatory submissions and support systems in Frederick, MD. This role... ...submission standards. Responsibilities include leading submissions, working with vendors, and overseeing document...Remote jobRegulatory
$130k - $160k
A leading diagnostics firm is seeking a Manager, Medical Writing, responsible... ...writing team and ensuring high-quality regulatory documents for market submissions. The role includes mentoring... ...pharmaceutical sector. The position is fully remote, offering a compensation range of $...Remote jobRegulatory$70k - $130k
...company is seeking a Senior Specialist in Regulatory Operations to manage regulatory submissions across their development pipeline. The role involves leading submission management and ensuring... ...field. The position can be remote or based at the company's office in...Remote jobRegulatoryWork at office$130k - $150k
.... The candidate will be responsible for producing high-quality regulatory documents and collaborating with cross-functional teams to ensure... ...offers a salary range of $130,000 - $150,000 USD annually, remote work flexibility, and a comprehensive benefits package. #J-1880...Remote workRegulatory- ...A clinical research organization is seeking a Regulatory Writer to manage and develop technical nonclinical documents. This full-time, remote position requires at least 2 years of writing experience in the pharmaceutical industry, strong analytical skills, and proficiency...Remote workRegulatoryFull time
- A leading clinical research organization is seeking a nonclinical regulatory writer to join their remote team. You will develop and manage comprehensive nonclinical documents while ensuring compliance with regulatory guidelines. Candidates should hold a BS in pharmacology...Remote jobRegulatory
- ...Description: Location: Remote (home-based in the U.S.... ...: Eastern Time Zone (EST) Employment... ...Programmer with extensive lead and co-lead experience,... ...compliance with regulatory standards and guidelines... ...committees and boards. - Submission Activities: Participate...Remote workRegulatoryContract workInterim roleWork from home
$130k - $150k
...writing experience in a Sponsor or CRO setting, along with a Bachelor’s degree in a scientific discipline. Responsibilities include leading the preparation of clinical trial documents and collaborating with various teams. Competitive salary between $130,000 and $150,000...Remote jobRegulatoryFlexible hours- ...Barrington James is seeking a Regulatory Affairs CMC Specialist/Manager to lead client regulatory CMC projects. This fully remote role requires 7+ years of regulatory affairs experience... ...expertise, and proficiency in managing submissions for INDs and NDAs. The successful...Remote workRegulatory
- ...A leading healthcare company is seeking a Manager of Regulatory Affairs based in remote locations. You will develop and execute regulatory strategies, manage FDA submissions, and ensure compliance for innovative medical devices. The ideal candidate has over 8 years of...Remote workRegulatoryFull time
- ...A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities....Remote workRegulatory
$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...Remote workRegulatory- ...biotechnology consulting firm is seeking a Regulatory Affairs Consultant to support... ...10-20 hours of work per week. This remote position requires expertise in regulatory... ...products. Responsibilities include leading regulatory submissions, engaging with the FDA, and...Remote workRegulatory10 hours per week
- ...Solventum is hiring a Principal Regulatory Affairs Specialist to lead regulatory submissions for their Dental Solutions business. This role requires a Bachelor'... ...supporting technical documentation revisions. The position is remote within the United States. #J-18808-Ljbffr...Remote workRegulatory
$155.68k - $202.38k
QuidelOrtho seeks a Senior Manager of Regulatory Affairs to lead and support regulatory strategies for the Transfusion Medicine Business Unit. Ideal... ...in regulatory strategy for product development. This remote eligible position prefers candidates from Raritan, NJ; Rochester...Remote workRegulatory- ...A leading regulatory consulting firm is seeking a Regulatory Affairs Consultant to support ongoing projects in Raleigh, NC. This remote role involves developing regulatory strategies, leading regulatory submissions, and interacting with the FDA. An advanced degree in...Remote workRegulatoryPart time10 hours per week
- ...healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville,... ...FDA regulations, and preparing regulatory submissions. Ideal candidates will have a bachelor’s... ...communication skills. This position is remote and requires some travel. Competitive...Remote workRegulatory
- A leading medical device company is seeking a Regulatory Affairs Specialist to develop and execute strategies for medical devices, including wearable technology... ...project management skills. You will lead FDA submissions and interact with regulatory authorities to ensure...Remote workRegulatoryFull time
- ...A leading biotechnology company is seeking a Regulatory Writing Senior Manager to lead writing activities for product submissions. This role involves authoring and overseeing regulatory documents... ...competitive salary and flexible remote work arrangements. #J-18808-Ljbffr...Remote workRegulatoryFlexible hours
- ...Gan & Lee Pharmaceuticals is seeking a Regulatory Affairs professional to support the implementation of regulatory strategies. Responsibilities include ensuring compliance for product submissions and regulatory interactions. The ideal candidate will have a Bachelor of...Regulatory
$176.4k - $207.5k
Recursion is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategies and oversee processes. This role requires at... ...compliance with regulatory requirements. The position is remote-friendly, with a salary range of $176,400 - $207,500 (USD)...Remote workRegulatory- ...rare disease company is seeking a Director/Senior Director of Regulatory Affairs. In this strategic role, you will manage global regulatory strategies for submissions in the US, EU, UK, and Japan. You will lead major submissions, engage with regulatory agencies like the...Regulatory
- ...company in Somerville is looking for a Sr. Regulatory Affairs Principal. This role involves... ...for high risk FDA Class III products, leading submissions and ensuring compliance with global... ...offers the flexibility to work remotely and requires excellent communication and...Remote jobRegulatory
- ...University Wexner Medical Center is seeking a Regulatory Compliance Officer to assure research... ...strategies and procedures for proposal submissions and communicating with sponsors for... ...relevant experience. The position offers remote work with office visits as necessary and...Remote jobRegulatoryWork at office
- ...POSITION OVERVIEW As a Global Regulatory Affairs Leadyour roles and responsibilities... ...Regulatory Affairs Manager to lead regulatory strategy, submissions, and compliance activities for... ...Location: Covington, Georgia Remote / Hybrid: On-site (4 days per week...Remote workRegulatoryPermanent employmentFull timeFor contractorsRelocation
- 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 jobRegulatory
- ...A leading generic pharmaceutical company is seeking an experienced Director... ...or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for pharmaceutical products. This... ...submissions. This position is remote eligible for candidates in the...Remote workRegulatory
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