Director, Global Regulatory Affairs — US/EU Submissions Strategy
HUTCHMED
HUTCHMED is seeking a (Sr.) Director of Regulatory Affairs to establish and lead the Regulatory Affairs function. This role involves supporting the global product team in developing registration strategies for product approvals in both the US and EU. The ideal candidate will provide regulatory guidance leveraging their expertise, manage submissions, and develop timelines in coordination with global partners. Requirements include a BS in health sciences, advanced degree preferred, and a proven track record in regulatory filings. #J-18808-Ljbffr HUTCHMED
$225k - $305k
Sr. Director, US Advertising & Promotion, Regulatory Affairs Field of work: Regulatory & Medical Posting... ..., you’ll guide the strategy, compliance, and... ...OPDP), ensuring timely submissions. Develop and implement... ...framework and procedures globally is a must. This includes...SuggestedWork at office- ...FUNCTION The (Sr.) Director, Regulatory Affairs role will establish... ...will support the global product team in the... ...global registration strategies for our pipeline which... ...our product/s within US and EU. The ideal candidate... ...approval and timely submission of regulatory filings...Suggested
$188.45k - $228.35k
## Director, Global S&OP Capability OwnerMadison - Giralda - NJ - USFind... ...with this job**Working with Us** Challenging. Meaningful. Life... ...and executing the overall strategy for continued excellence across... ....* Ensure compliance with regulatory requirements and company...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook ,... ...LinkedIn and Tik Tok . Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and...SuggestedFull timeTemporary workLocal areaWorldwide
$199.95k - $242.3k
## Director, Regulatory CMC - Cell TherapyMadison - Giralda - NJ... ...job**Working with Us** Challenging. Meaningful... ...direction based on global regulatory guidelines... ...oversee preparation of CMC submissions while ensuring... ...effective global regulatory strategies in coordination with...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$130k - $200k
...Full‑time Associate Director, Regulatory Affairs. Lead regulatory... ...(FDA and/or global) and collaborate... ...Regulatory Lead for US biologics programs... ...complex regulatory submissions (drafting, review... ...regulatory strategy/course of action.... ...Knowledge of FDA/EU regulations and ICH...Full timeTemporary work$244.99k - $296.87k
...job**Working with Us** Challenging. Meaningful... ...*Position Summary**Director of Biostatistics is... ...that will support regulatory approval and market... ...Development Plans, submissions, and post-submission strategies, preparations, and... ...SOPs, adherence to global and project...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$166k - $203k
...The Associate Director, Regulatory Affairs (Advertising and Promotion... ...review and approval of US promotional materials... ...regulatory compliance/strategy related to... ...responsible for all submission types made to OPDP/APLB... ...Medical Affairs, Legal, Global Regulatory Affairs, Labeling...Work at officeLocal areaWorldwide- ...leadership role will drive regulatory strategy across clinical and nonclinical... ...stage) outlined in Global Partner closely with Clinical... ...pharmaceutical Regulatory Affairs experience ~ Deep expertise... ...leading complex regulatory submissions and Health Authority...
$225k - $275k
Sr Director of Regulatory Affairs - North America Location: Morristown, NJ, US, 07960 Description Overview As Senior... ...Category Regulatory strategies into effective local... ...management, and submission readiness, working in... ...regulatory pathways, and global dossier expectations...Work at officeLocal areaRemote work2 days per week$156k - $234k
...cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the... ...and implement our global supply strategy, or work with our Procurement Centre... ...Finance. Assess geopolitical, regulatory, and macroeconomic risks to ensure...Contract workTemporary workLocal areaShift work- Senior Manager/Director, Regulatory Affairs (Generalist) Are you a regulatory... ...and established global organizations. We... ...client development strategies. No two projects are... ...pathways, submission strategy, and health... ...activities as a Global or US Regulatory Lead across...
$225k - $305k
...Madison, New Jersey, to shape the strategy and compliance for... ...States. You will manage the US Advertising and Promotion team... ...that all activities adhere to regulatory compliance while aligning with... ...significant experience in regulatory affairs, along with a strong...- Initial Therapeutics, Inc. is seeking a dynamic US Medical Director for Respiratory LCM to lead medical strategy for impactful treatments. This role integrates science with strategy to address patient needs in respiratory conditions. Candidates should have a strong background...
$242.7k - $404.5k
Daiichi Sankyo US is looking for a Senior Director, Clinical Safety Science to lead global safety strategy across the product lifecycle. This key role oversees a team of Safety Scientists and collaborates with various stakeholders for proactive safety surveillance and risk...$123.93k - $160.38k
...generations to come. Regulatory Submission Management acts as a partner... ...the portfolio, to ensure global Regulatory submissions are... ...across Regulatory Affairs, bridging strategy and execution while building... ...this position is: Other US Locations: $123,930.00 - $...Full timeFor contractorsWork at officeLocal areaFlexible hours$145.6k - $270.4k
Job Description Summary The Director Financial Controls & Compliance (FC&C) US will plan, execute, and ensure delivery... ..., SOX 404 requirements and strategies. The position leads the US FC&C team... ...relationships with senior local and global management, FC&C organization,...Local area- ...difference with. The Opportunitu Teva Global Operations (TGO) deliver... ...phase of our Pivot to Growth strategy, the Chief of Staff will play... ...Chain, Procurement, HR, Corporate Affairs…), track TGO’s performance and... ...opportunity, please advise us of any accommodations needed...Temporary workWork at officeFlexible hours
$181k - $260k
SUMMARY Zoetis seeks a strategic leader to build and scale pricing strategy capabilities across the U.S. Companion Animal & Diagnostics... ...position in Parsippany preferred. Hybrid role. COMPENSATION & BENEFITS US base salary range: $181,000 - $260,000. Short-term incentive...Temporary workWork at officeLocal area$185.5k - $344.5k
...Science. Reimagine incentive compensation strategies to align with evolving field roles,... ...measurement and incentive constructs across global or multi‑market teams while maintaining fairness... ..., eligibility for annual equity awards. US‑based eligible employees receive a...Remote workVisa sponsorshipRelocation package$141.5k - $268.5k
...AbbVie, please visit us at Follow @abbvie... ...important strategies and policy changes... ...work with Government Affairs and Legal to develop... ...Innovation Associate Director reports to the 340... ...statutory and regulatory changes related to... ...: 268500 Workday Global Grade: 20 Travel:...Full timeLocal area$198.99k - $221.1k
...together. Our Team, Your Impact Director Value & Access Strategy (V&A) - Inclusive of... ...Strategy works closely with US Innovative Medicines teams... ...Pricing and Contracting, Medical Affairs, and Account Management,... ...employment. It is Teva's global policy that equal employment...WorldwideFlexible hours- ...about AbbVie, please visit us at Follow AbbVie on LinkedIn... ...Description The Senior Manager, Regulatory Affairs US Advertising and Promotion... ...as needed. Supports the Director in efforts to influence the... ...Develops and guides implementation strategies for promotional activities....
$273.21k - $331.06k
Working with Us Challenging. Meaningful. Life... ...Description The Associate Director, Global Clinical Physician is... ...Expertise & Strategy Design and develop clinical... ...that align with regulatory disease strategy targets... ...briefing books, and submission documents. Degree Requirements...Summer workWorldwideFlexible hours$185.5k - $344.5k
...medicine and improve lives worldwide. As a global leader in healthcare, we leverage... ...that drive enhanced performance. The US CRM organization sits within IDS and plays... ...model. Reporting to the Executive Director, CRM Product Strategy, this role acts as the central authority...Remote workWorldwide- Novartis Pharmaceuticals Corporation is seeking an Executive Director of Business Excellence, CAR‑T, to lead strategic customer engagement... ...and drive business outcomes. With an emphasis on data-driven strategies, the Executive Director will collaborate across teams to...Remote job
$234k - $330k
Role Description: Support the Corporate Affairs team in driving global brand governance, content strategy and management focused on advancing the Zoetis brand by influencing... ...relationship management experience Compensation US base salary range for this full‑time position is $...Full timeTemporary workLocal area- Merck & Co. is looking for a Senior Director, Clinical Safety Science, to shape and advance global safety strategy throughout the product lifecycle. This leadership role oversees a team of Safety Scientists, ensuring proactive safety surveillance and risk mitigation. The...
$185.5k - $344.5k
...and ED, Portfolio & Pipeline Strategy to build forward looking competitive... ...assets. Help partner with US BD & L and US Market Access... ...the preparation of the FDP submission package, including commercial... ...experience partnering with Medical Affairs and/or Development to inform...$135k - $150k
...solutions to exceed customer expectations and better the world around us. With combined annual sales of more than $8.5 billion and 22,000+... ..., the DIC Group companies support a diverse collection of global customers. Sun Chemical Corporation is a subsidiary of Sun Chemical...Temporary workRemote workWorldwide
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