Global Labeling Strategy Lead, Associate Director
Us Tech Solutions
US Tech Solutions in Cambridge, MA seeks a Global Regulatory Labeling Strategy Lead (Associate Director) to guide regulatory labeling for plasma-derived therapies, interfacing with Clinical, Legal and Commercial teams to ensure compliant USPI, EU SmPC and labeling deliverables. You will drive CCDS labeling strategy, lead CCDS US/EU labeling teams, manage submission-ready components, and mentor cross-functional teams across regions while ensuring timely Health Authority interactions. #J-18808-Ljbffr Us Tech Solutions
- LanceSoft, Inc. is seeking a Global Regulatory Labelling Strategy Lead (Associate Director) for Plasma-Derived Therapies. This role guides labeling strategy across CCDS, US and EU labels, ensuring regulatory compliance and strategic input into submissions and negotiations...Suggested
- Discover International is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to guide strategic labeling and ensure regulatory compliance for plasma-derived therapies. You will influence internal stakeholders across Clinical, Pharmacovigilance, Legal...Suggested
- A leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires extensive experience... ..., to ensure alignment between US and global strategies. Exceptional communication skills...Suggested
- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology... ...RNA technology in the US and other global markets. Responsibilities Serve as the global regulatory lead delegate for development compounds in...Suggested
- Moderna seeks a Global Medical Lead to steer medical affairs strategy across our oncology portfolio, spanning early development through commercialization. You will lead a cross-functional team, oversee integrated evidence planning, and engage globally with regulators, payers...Suggested
- Sarepta Therapeutics in the United States is seeking a Senior Manager, Global Medical Affairs Strategy, RNA Therapeutics, to contribute to the GMAL team and advance Sarepta’s RNA therapies. This hybrid, on-site role blends strategic medical leadership with cross-functional...
- ...Senior Events Manager in Cambridge, MA. The role leads the strategy, design, and execution of CID’s public-facing... ...exceptional experiences and strengthening global engagement. The position reports to CID’s Senior Director of Communications and collaborates with a broad...Worldwide
- Sanofi in the US seeks a Global Periodic Reporting Lead based in Cambridge, MA (also Morristown, NJ and Swiftwater, PA). You will own the PSR authoring... ...across the portfolio. You will develop outsourcing strategies, ensure regulatory compliance, and drive Lean process improvements...Worldwide
- Job title Global Lead, Scientific Platforms & Engagement Strategy Location: Cambridge, MA, Morristown, NJ About The Job At Sanofi, we chase the miracles of science to improve people's lives. We are accelerating Sanofi's modernization journey, supporting our Take the Lead...
- Ipsen seeks a Global Brand Lead to shape and deliver the integrated global brand strategy for a specified asset, coordinating launch readiness and lifecycle growth across regions. You will lead cross-functional teams across Commercial, Medical, Market Access, Regulatory...
$142.5k - $256.5k
The Associate Director, Global Regulatory Advertising and Promotion will be responsible... ...and Promotional Labeling Branch (APLB) guidance, and... ...requirements. Guide promotional strategy as the Regulatory Ad Promo... ...Cross‑Functional Collaboration Lead discussions for assigned...Permanent employmentWork at officeWork from home- ...Job Description Job Description Associate Director, Global RA Labeling Lead – W2 - BB1309 BB10309 Cambridge, MA 6+ Months *Onsite Requirement... ...Target Label Profiles (TLPs) and leading labeling strategy for Company Core Data Sheets (CCDSs), U.S. Prescribing...2 days per weekEarly shift
$175k - $225k
...critical unmet need. As a global leader in myostatin biology... ...Summary of Position The Associate Director, Regulatory Strategy, is responsible for the development... ...successful candidate will lead interactions with the... ...development, clinical labeling, disclosure) as needed Candidate...Shift work- A leading biotechnology firm in Cambridge, MA is seeking an Associate Director of Security to develop and oversee a global security program. This role involves managing physical security measures, risk management strategies, and compliance with best practices. The ideal...
- 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
$161.5k - $218.5k
Overview The Associate Director, Downstream, Emerging Modalities, is expected... ...) purification as well as lead program(s) with the goal to... ...individual will lead purification strategy across internal and external... ...people. We're proud to be a globally recognized top employer,...Full timeTemporary workLocal areaFlexible hours$185.37k - $308.95k
Associate Director, Medical Review Lead, MSRM Who we are At Agios, we are fueled by connections to transform rare... ...review and partners closely with Global Safety Leads, Pharmacovigilance... ...that are connected to our business strategy and vary based on individual and company...Temporary workRemote workWork from homeFlexible hours3 days per week- Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US. Applicants should have...
- Harvard University’s Center for International Development (CID) is seeking a Senior Events Manager to lead CID’s global events program from Cambridge, MA. You will shape the annual portfolio, coordinate with faculty and leadership, and drive engagement with staff, fellows...
- Ipsen cherche un Directeur, Stratégie Patient Globale & Développement Marché - Migraine, basé à Cambridge (US). Le rôle définit la stratégie globale, comprend l’analyse du parcours patient et la mise en œuvre de plans de développement marché, en collaboration avec les é...
- Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, based remotely in the USA. The role partners with the Global Regulatory Lead to plan, coordinate, and deliver regulatory submissions across diverse programs...Remote job
- ...currently seeking to recruit an experienced Global Asset Lead (GAL) to take end‐to‐end accountability... ...) and business acumen (BD, portfolio strategy, and market dynamics).**Key... ...achieve a competitive and differentiated label that meets both regulatory requirements...Shift work
- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience...
- Moderna is seeking a Global Regulatory CMC Lead to coordinate CMC activities across product lifecycles and develop global regulatory strategies. You will guide product teams and manage multiple projects in a fast-paced environment to enable the next generation of medicines...
- J.Jill is strengthening its global transportation leadership to manage international freight, domestic transportation, and small parcel... ..., Planning, Distribution, and Finance to align transportation strategies with company objectives. A strong leadership track record is...
- Orion Pharma in Cambridge, MA, seeks a Global Asset Lead to own the strategic vision and delivery of a priority oncology program across development, regulatory, and commercial functions. You will lead a Global Program Team, coordinate Clinical, Regulatory, CMC, Medical...
- Alnylam Pharmaceuticals, Inc. in Cambridge, MA seeks a Director, Global Medical Affairs Technology. Lead strategy, portfolio, and governance for platforms, data products, and integrations enabling Medical Affairs, insights, omnichannel engagement, and RWE. Role partners...
$60.32k - $85.19k
...activate Northeastern’s Global Volunteer Network —... ...giving. Reporting to the Director, Leadership Relations,... ...international parent leads in partnership with... ...donor challenge gift strategy. Communicate on Behalf... ...communities and their associated volunteer community leaders...Full timeWork experience placementFlexible hoursShift work$76.34k - $107.82k
...across Northeastern University's global campus network, Global... ...Global Entrepreneurship, the Associate Director will serve as a strategic partner... ...agenda. Working across strategy, partnerships, ecosystem development... ...ecosystem. Experience leading complex strategic projects...Full timeWork experience placement- ...University CID in Cambridge, MA, seeks a Senior Events Manager to lead strategy, design, and execution of CID’s public-facing events worldwide... ...and drive exceptional experiences that strengthen CID's global engagement. The role requires collaboration with faculty and leadership...Worldwide
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