Senior Regulatory Affairs Manager - EU CTAs & Submissions
$119k - $190kBrave
Brave in San Francisco is seeking a (Senior) Manager, Regulatory Affairs to support global regulatory submissions, focusing on EU and ex-U.S. Clinical Trial Applications. With a minimum of 5 years of experience, the ideal candidate will manage CROs and coordinate cross-functional deliverables, ensuring compliance with EU regulatory frameworks. This role requires strong project management skills and the ability to thrive in a fast-paced environment, with potential for a competitive salary ranging from $119,000 to $190,000. #J-18808-Ljbffr Brave
$119k - $190k
...therapeutic area. The role: The (Senior) Manager, Regulatory Affairs will be a key contributor to... ...Bio’s global regulatory submissions, with a primary focus on European Union (EU) and ex-U.S. Clinical Trial... ...) responsible for preparing CTAs, as well as coordinate...SeniorFlexible hours$140k - $214k
Vera Therapeutics in Brisbane, California is looking for a Senior Manager, Regulatory CMC to drive regulatory submissions in a collaborative environment. The role involves managing CMC aspects of clinical products and ensuring regulatory compliance. Ideal candidates will...Senior- A national recruiting company is seeking a skilled Project Manager to oversee project management of drug development processes... ...Responsibilities include leading cross-functional teams, managing regulatory submissions, and ensuring projects meet business needs. Ideal...Senior
$240k - $275k
...International Executive Service Corps is hiring a Director of Clinical Regulatory Affairs to shape and execute the global clinical regulatory strategy. The role involves overseeing clinical submissions and ensuring compliance with regulatory requirements. The ideal...Senior- Senior Manager, Regulatory Affairs Position Overview Sutro has a unique capability that enables new molecular... ..., review, and planning of submissions to regulatory agencies including FDA... ...maintenance of these applications (INDs, CTAs, DMFs, BLAs, MAAs). Ensures regulatory...SeniorWork at office
$280k - $320k
...Sr. Director of Medical Writing to oversee all scientific, medical, and regulatory writing activities. This role ensures full life-cycle support from clinical protocols through regulatory submissions. The ideal candidate will have a strong background in scientific...Senior$165k - $195k
...leadership and support to global regulatory activities to achieve... ...will represent Regulatory Affairs and work closely with cross... ...Lead preparation, review and submission of INDs/CTAs, amendments, review and... ...investigator document packages and manage other regulatory activities...SeniorHourly payContract workWorldwide$150k
Premier Research Group is seeking a Regulatory Strategy Director for the Bay Area or Boston. You will lead regulatory program strategies... ...projects. This role requires deep expertise in regulatory submissions, with preferred qualifications being a relevant degree and extensive...Senior- ...in pharma/biotech R&D focusing on Global Regulatory Affairs, regulatory operations, regulatory technology, or data product management. Strong track record in data product development... ...with multi-modal regulatory data (submission, labelling, intelligence, compliance datasets...SeniorContract workFixed term contract
$140k - $214k
...Position Summary Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast‑paced... ...team to lead and support regulatory submissions and activities in the US and globally... ...requirements. Represent Regulatory Affairs on cross‑functional project teams. Evaluate...Senior- ...are seeking a Director of Regulatory Affairs Strategy to lead the development... ...visibility with senior leadership and the opportunity... ...assigned programs, including US, EU, and key international... ...planning, authoring strategy, and submission of INDs, CTAs, BLAs, NDAs, and MAAs in...
- A dynamic biopharmaceutical company in San Francisco seeks a Regulatory Affairs Director to lead strategies for late-stage oncology assets. Responsibilities include overseeing submissions, engaging with FDA and EMA, and ensuring compliance with regulations. Candidates...Work at office
- ...multinationals. The firm is looking for a senior director of fintech legislative and regulatory affairs for global clients, expanding... ...is high. Key Responsibilities Management Develop regulatory strategy on... .... Supervise and edit their submissions before deliverables are sent...SeniorFull timeFor contractorsWork at office
- ...are looking to hire a Head of Regulatory Affairs for our Clinical/Regulations... ...) alongside US timelines Submissions & regulatory documentation... ...FDA inspections Write and manage Q-Sub (pre-submission)... ...strategies, including CE Mark / EU MDR, PMDA (Japan), NMPA (China...
$220.6k - $275.7k
...average. Position Summary The Senior Director, Regulatory Operations provides strategic and... ..., overseeing electronic submissions, regulatory information management systems, and end‑to‑end submission... ...member of the Global Regulatory Affairs Leadership Team and plays a critical...SeniorWork at officeLocal areaRemote workWorldwideNight shift3 days per week- ...The Role You’ll own the regulatory strategy and FDA-... ...as we move through IDE submission, our pivotal trial, and... ...with Faiyaz (VP Program Management) on submission... ...+ years in regulatory affairs at medical device companies... ...regulatory strategy: CE Mark / EU MDR, PMDA (Japan),...Permanent employmentRemote work
$195.5k - $272.5k
...enthusiastic Director of Regulatory CMC accountable... ...regulatory submissions that... ...and Regulatory Affairs department to plan... ...registration for INDs, CTAs, BLAs and MAAs... ...issues Manage CMC regulatory... ...experience (US, EU, UK, CA,). Working... ...present to Senior Management WHO...Full timeWork at officeWork visa3 days per week$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco,... ...strategies for drug approvals and submissions. Candidates should have... ...extensive experience in Regulatory Affairs CMC within the biotech or... ...industry and be adept at managing complex global submissions....Remote job- BridgeBio Pharma in California is seeking a Regulatory CMC professional to lead the regulatory strategy for IND, NDA, and MAA submissions. The role requires extensive experience in regulatory affairs within biotechnology and a strong ability to mentor team members. Responsibilities...SeniorRemote jobWork at office
- ...product innovation, providing oversight to key deals and projects, managing strategic relationships and demonstrating thought leadership... ...Customer Success, Consulting, etc.) Confident in presenting to senior stakeholders Nice to Have High level understanding of Marketing...SeniorWork at officeWork from home
$285k - $320k
...work. What You’ll Do Lead CMC regulatory strategy and execution across... ..., ensuring high‑quality submissions aligned with global regulatory... ...mentor, coach, and potentially manage team members as organizational... ...preferred Extensive Regulatory Affairs CMC experience within the...SeniorFull timeWork at officeRemote workFlexible hours$225k - $250k
...United States. They are seeking a Regulatory Affairs Director who can lead the... ...across regions. Regulatory Submissions: Oversee the planning, preparation, and management of regulatory submissions for... ...mitigation strategies. US/EU Regulatory expertise: Provide...Work at officeLocal areaFlexible hours- ...backers at About the Role We’re looking for a Policy & Regulatory Affairs Manager to help shape and execute our policy and regulatory strategy... ...teams Support advocacy efforts, including meetings, submissions, and public‑facing initiatives Minimum requirements 5+...Work from homeFlexible hours2 days per week
- ...Investigations Team, responsible for leading quality and professional practice investigations. This role demands 10+ years of experience, regulatory knowledge, and exceptional analytical skills. Candidates should possess a strong ability to communicate effectively and influence...SeniorFlexible hours
$235k - $285k
...highly motivated Director/Senior Director of Regulatory Affairs to lead regulatory strategy... ...regulatory plans and submissions to support preclinical and... ...documents, including INDs, CTAs, amendments, briefing packages... ...authority inquiries. Manage interactions with FDA and...SeniorFull time- ...Director, Regulatory Affairs Position Title: Director, Regulatory Affairs... ..., nonclinical and clinical submissions and interactions in support... ...and life cycle management activities. This position works... ...submissions (including IND, CTAs, NDAs, and MAAs) for early...For contractorsWork at office
- ...division. As part of this growth, the organization is seeking a Regulatory Affairs Manager CMC to join their Regulatory team in San Francisco. This... ...to play a hands-on role in regulatory strategy and submissions, supporting both U.S. and global regulatory filings while...
$127k - $165k
...Manager, Regulatory Affairs page is loaded## Manager, Regulatory Affairsremote type: Fully Remotelocations... ...and talent development* Lead FDA submissions (510(k) or pre-submissions) with the... ...product life cycle management* Lead EU MDR Technical Documentation and other...Full timeWork at officeRemote work$186k - $233k
...years in oncology trials. The role entails leading studies, collaborating with teams, and overseeing programming support for regulatory submissions in a dynamic environment. This opportunity offers competitive pay, from $186,000 to $233,000, depending on market...Senior- A leading fintech firm is seeking a Senior Product Manager to coordinate complex product areas focusing on investment processes. This hybrid role based in San Francisco requires a strong individual with extensive product management experience, particularly in regulated...Senior
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