Global Regulatory Affairs: Associate Director & Strategist
Ipsen Biopharmaceuticals Inc.
Ipsen Biopharmaceuticals Inc. seeks an Associate Director, Global Regulatory Affairs to lead regulatory strategies for our portfolio, coordinating with R&D, Franchise, and Commercial teams. The role requires directing global regulatory activities, ensuring timely and compliant submissions, and driving continuous improvement across programs. Ideal candidates will have 7+ years in Regulatory Affairs, advanced scientific degree, and proven ability to influence stakeholders and manage complex #J-18808-Ljbffr Ipsen Biopharmaceuticals Inc.
- Ipsen Biopharmaceuticals Inc. is seeking an Associate Director, Global Regulatory Affairs in the Cambridge, MA area. The role leads regulatory strategy and execution for development and marketed products, interfacing with R&D, Franchise, and Commercial teams to ensure compliant...Suggested
$154.4k - $242.55k
...guidance to teams for the delivery of global regulatory strategies to support development and... ...Effectively represent the Global Regulatory Affairs (GRA) function in senior level... ...guidance comments and supporting trade association working groups.Education & Competencies...SuggestedMinimum wageLocal areaRemote work$154.4k - $242.55k
...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of...SuggestedMinimum wageLocal areaRemote workWorldwide- ...Ipsen seeks an Associate Director of Global Regulatory Affairs to develop and execute regulatory strategies for assigned biopharmaceutical programs. This role bridges R&D, commercial operations, and regulatory functions, ensuring compliant implementation across development...Suggested
- ...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of...SuggestedWorldwide
- Title: Associate Director, Global Regulatory Affairs Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported...Local areaWorldwide
- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure FDA and global promotional compliance across channels. You will serve as a liaison among Regulatory Affairs, Legal, Medical, and Commercial teams to align regulatory strategy...
- Takeda's Global Regulatory Affairs - CMC team in Cambridge, MA is seeking a Regulatory CMC professional to lead regulatory submissions for investigational, registration and post-approval programs across global markets. With minimal supervision, you will define CMC content...
$154.4k - $242.55k
...make a lasting impact on patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global... ...such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively...Minimum wageLocal areaRemote workWorldwide- Moderna is seeking an Associate Director, Global Regulatory Affairs, CMC, to lead and oversee regulatory activities for CMC and Quality, coordinating worldwide submissions and agency communications. The role requires 10+ years in pharma/biotech with strong EU/ROW regulatory...Work at officeWorldwide
$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic...Permanent employmentWork at office- ...Description Job Description Title: Associate Director, Signal Management & Innovation... ..., and management activities within a global Patient Safety organization. This role... ...closely with Pharmacovigilance, Global Regulatory Affairs, Data Sciences, Medical Safety, and other...Remote job
$186.23k - $279.35k
...Provide strategic and operational regulatory leadership to the... ...knowledge of current local and global Regulatory trends to identifyfuture... ...agencies and trade associations on product and legislativedevelopment... ...and local Regulatory Affairs interface enabling rapid andeffective...Full timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week- ...Therapeutics is seeking an Associate Director of Regulatory Strategy to support... ...creative and agile regulatory strategist able to anticipate and address... ...in the US and other global markets. Responsibilities... ...May serve as regulatory affairs representative to provide...
- Ipsen Biopharmaceuticals Inc. seeks an Associate Director, Global Regulatory Affairs to lead regulatory strategies for development and marketed products across regions. The role interfaces with R&D, Franchise, and Commercial Ops, ensuring compliant, efficient execution...
- ...in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs... ...extensive experience in regulatory affairs, particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills...
$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data...Full timeTemporary workLocal areaWorldwideFlexible hours2 days per week$161.6k - $242.4k
Job DescriptionGeneral Summary:The Regulatory Labeling Associate Director will be responsible for strategic labeling... ...one or more products either at the global label-level (CCDS, USPI, EuSmPC) or... ...8 years of experience in regulatory affairs in the area of global labeling or...Full timeSummer workWork at officeRemote workFlexible hours2 days per week$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic...Full timeTemporary workWork at officeLocal areaFlexible hours$166.4k - $249.6k
...DescriptionGeneral Summary:The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed... ...in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or...Full timeSummer workRemote workFlexible hours2 days per week$154.4k - $242.55k
...company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory...Minimum wageFull timeLocal areaRemote workWorldwide$166.4k - $249.6k
...General Summary The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed... ...in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another...Summer workRemote workFlexible hours2 days per week$161.6k - $242.4k
## Regulatory Labeling Associate DirectorApply: Boston, MA: Full time: Posted Today:... ...Regulatory Labeling Associate Director will be responsible for... ...more products either at the global label-level (CCDS, USPI, EuSmPC... ...experience in regulatory affairs in the area of global...Full timeSummer workWork at officeRemote workFlexible hours2 days per week- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and... ...communication and leadership skills. This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema Pharma AG
$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing...Permanent employmentFull timeWork at officeWork from home$70k - $150k
...Associate Manager, Financial Investigations Kroll's North American Investigations, Diligence... .... A key interest in business strategy, global events and markets, with an awareness of... ...investigations, forensic accounting, regulatory compliance, internal (client)...Temporary workInterim roleFlexible hours$142.5k - $256.5k
...The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing...Permanent employmentWork at officeLocal areaWork from home- Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in Watertown, MA with in-office presence at least 3 days a week. The role will own INDs/CTAs, health authority...Work at office3 days per week
$170k - $195k
...What's the opportunity? We are seeking a highly skilled Associate Director, Regulatory Affairs to support and help drive regulatory success and shape... ...and agency interactions. The ideal candidate brings solid global experience navigating complex regulatory environments,...Work experience placementShift work- Sanofi in Cambridge, MA seeks a Global Customer Experience Business Partner to embed an omnichannel vision into brand and franchise strategies and drive end-to-end execution across global and local teams. You will translate global customer experience into local campaigns...Local area
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