Global Regulatory Affairs: Associate Director
Ipsen ADR
Ipsen Biopharmaceuticals Inc. in Cambridge, MA, seeks an Associate Director, Global Regulatory Affairs to shape regulatory strategies for development and marketed products worldwide. You will guide regulatory asset teams and collaborate with R&D, Franchise, and Commercial Operations to ensure timely, compliant submissions. The role requires 7+ years in Regulatory Affairs, strong project management, excellent communication, and a proven ability to lead cross-functional teams. #J-18808-Ljbffr
- 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
...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$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$190k - $210k
...Associate Director, Global Regulatory Affairs, Compliance Responsibilities Translate applicable laws, regulations, and guidance into practical regulatory compliance strategies supporting development and business objectives. Support high-quality, timely execution of regulatory...SuggestedFlexible hours$153.6k - $241.34k
...Associate Director, Global Regulatory Affairs – GI & Inflammation Apply for the role at TakedaPharmaceutical Nordics AB. Job Description Associate Director responsible for regulatory affairs for GI & Inflammation programs. Provides strategic and tactical advice, leads...SuggestedFull timeTemporary workRemote work$190k - $210k
...Associate Director, Global Regulatory Affairs ComplianceOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. It's an exciting time to be part...Work at officeFlexible hours2 days per week- ...Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. The Associate Director...Full timeRemote workWorldwide
- ...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...Worldwide
- ...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...
- ...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...
- 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
- ...Galderma in Boston, MA is seeking an Associate Director, Global R&D Compliance Lead to oversee the R&D compliance program, manage GFRC, and advise on investigator-initiated studies, regulatory changes, and training across a global, matrixed organization. This role requires...
- 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...
$155k - $190k
...Associate Director, Global Regulatory Affairs At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team...Full timeLocal areaFlexible hours$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$142.5k - $256.5k
...The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic...Permanent employmentWork at office- 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
- ...Job Title Associate Director, Global R&D Compliance Lead Job Location Boston, MA The Opportunity... ...(including Global Medical Affairs). Oversees Galderma’s compliance program... ...meeting activities. Monitors the regulatory and broader compliance environment to...Work experience placementWork at officeLocal areaWorldwideFlexible hours
- ...Associate Director, Global Regulatory Project Management And Strategic Planning - Oncology TauAt Takeda, we are a forward-looking, world-class R&D organization... ...Planning - Oncology Tau within our Global Regulatory Affairs organization, based remotely.Partners with the Global...Remote workWorldwide
- ...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...
$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- 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...
$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- ...Amgen seeks an Associate Regulatory Affairs Director to oversee cell therapy regulatory strategy and submissions across global regions. You will partner with senior teams to advance innovative therapies through clinical development and guide cross-functional teams on compliance...
- ...AVEO Oncology is seeking an Executive Director, Global Regulatory Affairs to provide strategic and operational leadership for global regulatory activities across the company’s oncology portfolio. You will be accountable for the development and execution of integrated global...
$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- ...life and survival for people with cancer. What you'll be doing As a key member of the Nuvation Regulatory Affairs team, you will collaborate with a cross-functional team and global licensing partners to further develop commercial stage assets. We are looking for an...Full timeFor contractorsLocal area
$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
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