Global Regulatory Submissions Specialist
Net2Source (N2S)
A leading staffing solutions provider based in San Diego is looking for a Regulatory Affairs Associate. This role involves providing regulatory support for US and global submissions, ensuring full compliance with documentation. Candidates should have a Bachelor's degree and at least two years of experience in Regulatory Affairs within the Medical Products Industry. Strong understanding of FDA, EU regulations and communications skills are crucial. Competitive hourly pay is offered for a contract duration of 12 months, with potential for extension. #J-18808-Ljbffr Net2Source (N2S)
- Dexcom Corporation is seeking a Regulatory Affairs professional to support regulatory activities for Dexcom software products and develop global regulatory strategies for submissions in the US, EU and Canada. You will collaborate with regional teams, review software labeling...SuggestedRemote job
- Dexcom Inc. is seeking a Regulatory Affairs Specialist to support development activities for our CGM software... ...and to develop regulatory strategies for submissions worldwide. You will collaborate with regional teams to align global regulatory plans and ensure labeling and...SuggestedWorldwide
- Barrington James in San Diego seeks a Regulatory Affairs Specialist/Senior Specialist to lead complex global submissions (FDA, EU Notified Bodies) and guide product lifecycle compliance in a fast‑paced diagnostics environment. Strong communication and project management...Suggested
- Neurocrine Biosciences is seeking a Regulatory Affairs professional to coordinate submission packages for regulatory authorities, including INDs and annual reports. The role requires strong knowledge of FDA regulations, ICH guidelines, and robust project management skills...Suggested
- Neurocrine Biosciences is seeking a regulatory submissions coordinator to prepare and manage regulatory filings for clinical trials and product registrations. You will ensure compliance with FDA/ICH guidelines, reviews, and maintains documentation across submission lifecycle...Suggested
$71.6k - $119.3k
...Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring... ...scale stands before us. Meet The Team Regulatory Affairs is a team of more than 40 professionals... ...regulatory strategies and prepare submissions in various countries (US, EU, Canada)....Work at officeRemote workWorldwideHome officeFlexible hours$240k - $275k
San Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will provide strategic regulatory leadership across Janux... ...including EU Clinical Trial Regulation (CTR) and CTA submissions.Serve as the primary regulatory contact with...Full timeSummer workWork at officeRemote workRelocationRelocation packageShift work$90k - $95k
...limits of innovation and supply in global health. With over 2,100 employees across... ...Job Type: Full time Job Title: Regulatory & Compliance Specialist Location: Onsite - San Diego... ...documents in support of regulatory submission (De Novo and 510K) for IVD products....Full time- Cymbiotika, based in San Diego, is seeking a Regulatory Compliance Specialist to support product compliance and regulatory initiatives across dietary supplements, foods, and cosmetics. The role ensures products are manufactured, labeled, and marketed in line with US and...
$258.68k - $313.46k
...lives. Read more: careers.bms.com/working-with-us.Sr Director, Global Regulatory Strategy, NeuroscienceWill be a key member of the GRSP... ...dealing with them.Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...Therapeutics, Inc. in San Diego, CA, is seeking a Director of Regulatory Affairs to lead global regulatory strategy, oversee NDA filings, and coordinate... ...authority interactions. The role includes managing submission documents, lifecycle planning, and supervising external...
$228k - $245k
Overview The Director, Global Regulatory Affairs will play a critical role in developing and implementing regulatory strategies to support... ...and sub-teams for one or more programs. Lead the preparation, submission, and maintenance of regulatory filings (INDs, NDAs, BLAs,...Full timeSummer workWork at officeRemote workRelocation packageMonday to Friday$105.8k - $132.25k
Regulatory Affairs Specialist 3 - Medical Device IVD Location: CA-San Diego, US Contract Type: Regular... ...of millions of people? Grifols is a global healthcare company that since 1909... ...pre‑market and post‑market regulatory submissions with the US FDA, Notified Bodies in...Full timeContract workWork at officeLocal area- Regulatory Affairs Specialist/Senior Specialist We're currently supporting A global healthcare diagnostics organization focused on developing and delivering innovative diagnostic... ...pre-market and post-market regulatory submissions with the US FDA, Notified Bodies in the EU...
- ...Excel skills. Responsibilities include supporting audits, conducting root cause analysis, and delivering training for the Americas. Travel up to 10% is possible as part of global trade compliance initiatives and ongoing policy updates. #J-18808-Ljbffr Trane Technologies
- Argen Corporation in San Diego seeks a Regulatory Affairs Specialist to ensure compliance for regulated dental products. The role includes maintaining regulatory documentation, licensing, and supporting audits. The ideal candidate has a Bachelor's degree and over 5 years...
- Acadia Pharmaceuticals seeks a Director, Regulatory CMC to lead global regulatory strategies for small molecules, from development through commercialization. You will guide IND/CTA filings, NDA/MAA submissions, and lifecycle management, coordinating with R&D, Manufacturing...
$110k - $125k
...Role Overview Cymbiotika is seeking an experienced Regulatory Compliance Specialist to support product compliance and regulatory initiatives... ...registrations, notifications, certifications, and other regulatory submissions for applicable international markets, including Health...Remote workWork from homeFlexible hours- Planet Pharma is seeking an Associate Director, Regulatory Project Manager to lead and coordinate global regulatory activities for rare disease therapies. You... ...timelines, cross-functional collaboration, and submission readiness across INDs, NDAs, BLAs, and post‑marketing...
$91.7k - $137.53k
Job SummaryPosition Overview: The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including working with Marketing, New Product Development, Manufacturing and Engineering...Full timeWork at office- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across... ...high-quality CMC content for regulatory submissions, provide phase-appropriate regulatory guidance...Work at officeFlexible hours
$150k - $195k
...RegulatoryLocation:San Diego, USA- RemoteBe a part of a global team that is inspired to make a... ...Summary:The Associate Director, CMC Regulatory Affairs is responsible for providing... ...responsible for driving CMC regulatory submissions, managing Health Authority interactions...Full timeTemporary workRemote work- ...available in the US and around the world. Regulatory Affairs Consultant, In Silico Modeling... ...activities in support of all regulatory submissions. Serve as the primary company contact... ...regulatory positions to the FDA and other global agencies, leveraging data from in-silico...Local areaRemote work10 hours per week
- ...last 3 years with over 5500+ employees globally, with over 30+ locations in the US and... ...Company: One of Our Clients Job Title: Regulatory Affairs Associate Duration: 12 Months... ...expertise associated with US and global submission requirements, including analysis of the...Work at officeWorldwideHome office
$150k - $195k
...RegulatoryLocation:San Diego, USA- RemoteBe a part of a global team that is inspired to make a... ...Summary: The Associate Director, Regulatory Project Manager (RPM) at Travere Therapeutics... .... This role supports regulatory submissions for investigational and commercial rare...Full timeTemporary workRemote workShift work$228k - $245k
...A biotechnology firm is seeking a Director of Global Regulatory Affairs in San Diego. This role involves developing and executing regulatory strategies to support clinical programs and interaction with global regulatory agencies. Candidates should have a BS in life sciences...$260k - $365k
Greenberg Traurig (GT), a global law firm, has an exciting full-time employment opportunity... ...senior level Associate in the Financial Regulatory & Compliance Practice. This position can... ...your resume and official transcript(s).*Submissions from search firms will only be accepted...Full timeTemporary workWork at officeFlexible hours- ...Associate Regulatory Affairs ManagerCorDx a multi-national biotech... ...of innovation and supply in global health. With over 2,100 employees... ...development, review, and submission of regulatory documents for... ...and mentorship to junior staff or specialists on assigned projects....Full time
- ...Customs Manager in San Diego to develop, implement, and govern a global customs strategy with a strong focus on U.S. compliance. You... ...relationships with internal and external stakeholders, monitoring regulatory changes, and representing the company in dealings with customs...
- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology Type Public Company About the Role The Company is seeking a Head of Global Regulatory Advertising and Promotion...
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