Director, Global Regulatory Labeling Strategy
Core4ce Careers
Akebia Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to ensure labeling complies with FDA and global requirements. You will influence senior stakeholders, oversee USPI/CCDS labeling, manage SPL submissions, and drive lifecycle labeling from development through post-marketing. This role supports hybrid in-office engagement amid relocation plans to Waltham. #J-18808-Ljbffr Core4ce Careers
- Alnylam is seeking an experienced labeling professional to join our labeling strategy team. This team is responsible for developing initial... ..., PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product,...SuggestedLocal area
- Akebia Therapeutics seeks a Director, Regulatory Affairs - Labeling to shape global labeling strategy across our portfolio. You will serve as the enterprise expert on labeling, partnering with Clinical, Medical Affairs, Commercial, Legal, Safety, and CMC to ensure robust...Suggested
- Job DescriptionGeneral Summary:The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products. This role will... ...markets (e.g., US, EU, GB, CA).Lead labeling strategy with expert ability to advise stakeholders of...SuggestedFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week
- ...LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing... ...global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as...SuggestedTemporary workWorldwide
$167k - $300.7k
The Role Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the... ...Director will be a strategic leader within Global Regulatory Science, responsible for... ...and maintenance of the Target Label Profile and the Company Core Data Sheet...SuggestedPermanent employmentWork at officeWork from home$155k - $190k
...perspectives, and experiences to join our team. What You’ll Do The Associate Director, Global Regulatory Labeling and Ad Promo will be initially responsible for product labeling and non-promotional strategies to support organizational goals while maintaining regulatory...Full timeLocal areaFlexible hours3 days per week$180k - $245k
...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs... ...for developing and executing regulatory strategies that support global product development and registration...$196.7k - $353.4k
The RoleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and...Permanent employmentFull timeWork at officeWork from home- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of... ...vaccines based on messenger RNA technology in the US and other global markets. Responsibilities Serve as the global...
- ...company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires... ...particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and...
$154.4k - $242.55k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of... ...counterparts.Accountabilities:The Associate Director will be responsible for complex or... ...sub-working groups, such as the Label Working Group, and represents GRTs...Minimum wageTemporary workLocal areaRemote work$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for the company's early-stage and pipeline programs in the immunology and inflammation (I&I) therapeutic area, with...Local areaFlexible hours2 days per week$268.2k - $402.2k
...DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory... ...and implementation of innovative global regulatory strategies for product development... ...data, protocols, safety reporting, labeling and other activities related to the...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston... ...to role: Are you ready to set the global regulatory direction for first-in-... ...complex programs to competitive labels and rapid, global patient access? This...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$238k - $374k
...therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ...innovative and robust regulatory strategies for medical devices and drug-device... ...nonconformances, clinical evidence, labeling/UDI, post-market signals). Anticipates...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$177k - $278.08k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing... ...develops the regulatory CMC strategy and leads the execution of regulatory... ...Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies...Minimum wageTemporary workLocal areaRemote workWorldwide$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical... ...strategy for the assigned global or regional position and will be responsible... ...data, protocols, safety reporting, labeling and other activities related to the...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston... ...to role: Are you ready to set the global regulatory vision for pioneering... ...competitive pathways to approval and labeling. You will shape strategy for complex...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$200k - $265k
...opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage...Full timeTemporary workWork experience placementWork at officeWorldwide$209.35k - $258.6k
Regulatory AffairsCambridge, MA • ID: 26R-19 • Full-Time/RegularThis... ...all in, are you?Job Summary:The Director, Regulatory Affairs - Labeling is a highly visible leadership role... ...for shaping & executing global labeling strategy across Akebia’s entire portfolio...Full timeWork at officeLocal areaRelocationFlexible hours- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... .... This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate...
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead regulatory plans for select programs in rare, autoimmune, and oncology portfolios. This role requires strategic leadership within Global Regulatory Science to address challenges in gaining market approval...
$189k - $246k
Department: 107000 Regulatory Location: San Diego, USA- Remote Position Summary The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and... ...regulatory leadership for label development and...Temporary workLocal areaRemote workWeekend work- ...seeks a Chemistry Manufacturing Controls Manager to oversee regulatory CMC submissions and strategic interactions with agencies.... ...partner with development and manufacturing teams to shape global CMC strategies for investigational and marketed products, while supporting...Remote work
- Stoke Therapeutics, Inc. is seeking a Director, Global Regulatory Strategy to lead regulatory strategy across programs, interfacing with FDA and other agencies. Hybrid position based in Bedford, MA with relocation to a new location in Waltham by end of 2026. Role includes...Relocation
- Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high-impact oncology programs. You will collaborate with cross-functional teams to...
- Summary of Position The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs, is responsible for the development and... ...(e.g., SOPs, business development, clinical labeling, disclosure) as needed Education in life sciences...Work at officeLocal areaShift work
- Stoke Therapeutics seeks a Director of Global Regulatory Strategy to lead global regulatory planning, ensuring products move through development, approval, and maintenance in line with health authority expectations. The role reports to the Executive Director and requires...
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios. You will shape strategy, communicate risks and opportunities, and negotiate with health authorities in the US and...
$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates should...
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