Remote Global Regulatory Strategy Lead
Sarepta Therapeutics Inc
- Remote job
Sarepta Therapeutics is seeking a Regulatory Affairs Clinical Lead to guide regulatory strategy and submissions for assigned markets. You will work cross-functionally to support clinical trial activities, post-licensing activities, and communication with regulatory authorities. This US-based remote/hybrid role requires 5+ years in regulatory affairs, knowledge of ICH guidelines, IND/CTA, and experience preparing submissions. #J-18808-Ljbffr Sarepta Therapeutics
- ...in the Lake County IL area seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead regulatory strategy and tactical planning for US and... ...on a hybrid schedule (3 days in office, 2 days remote) with a strong emphasis on collaboration across global...Remote workRegulatoryWork at office
- Travere Therapeutics in San Diego seeks an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. You will develop, negotiate, implement and maintain labeling content including USPI, CCDS, and TPL, collaborating with Regulatory...Remote jobRegulatory
$230.4k - $345.6k
...delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to... ...s high regard for our employees. The Director, Global Regulatory Strategy Lead will provide strategic regulatory guidance and leadership throughout...Remote workRegulatoryFull timeContract workLocal areaWorldwideRelocation- ...LLC is seeking a Manager, Marketing Content Strategy for CGT to lead global content strategy and messaging across... ...Product Management, Commercial, R&D, and Regulatory to drive adoption and education. This role can be remote within the United States and requires 8+ years...Remote jobRegulatory
- Sarepta Therapeutics is seeking a Regulatory Affairs Lead to guide clinical trial activities, review CRO submissions, and support regulatory strategy across markets. This US-based remote role requires collaboration with cross-functional teams and a strong emphasis on timely...Remote jobRegulatory
- Sarepta Therapeutics is seeking a regulatory affairs professional for a US-based remote role. You will lead regulatory activities for clinical trials, coordinate submissions... ...-functional teams to implement regulatory strategies and ensure compliance with evolving guidelines...Remote jobRegulatory
- 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 jobRegulatory
- Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, based remotely in the U.S. Massachusetts/Cambridge area. This role partners with the Global Regulatory Lead to ensure robust global project plans, cross-...Remote jobRegulatory
- ...Tiergesundheit AG is seeking a Sr Scientist - Global Regulatory Project Lead in Indianapolis, IN. This role involves guiding regulatory strategy and leading submissions for farm and... ...position offers flexibility with hybrid and remote options along with a comprehensive...Remote workRegulatory
- ...regenerates life in depleted soils globally with naturally occurring,... ...Summary: The Global Regulatory Affairs Lead is responsible for defining... ...Oath’s globalregulatory strategy to achieve and maintain "Freedom... ...Location: Home-based / Remote (USA-based preferred for proximity...Remote workRegulatoryLocal areaWork from homeShift work
- ...seeks an experienced Program Manager – Global Workforce Solutions to shape a scalable... ..., CBO portfolio owners and SMEs to turn strategy into practical, global operating models... ...of standards across markets while respecting local regulatory differences. #J-18808-LjbffrRemote workRegulatoryLocal area
$143k - $180k
...the better. Chiesi Global Rare Diseases... ...help translate medical strategy into disciplined execution... ...and operating rhythms, lead high-priority initiatives... ...policies and applicable regulatory requirements. Performance... ...Location USA (Remote), with travel to Chiesi...Remote workRegulatoryHourly payFull timeLocal areaRelocation packageFlexible hours$177k - $278.08k
...worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...you will set global regulatory strategy and lead major submissions for high-impact... ...hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1...Remote workRegulatoryMinimum wageFull timeLocal areaWorldwide$177k - $278.08k
...worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...Oncology you will set global regulatory strategy and lead major submissions for high-... ...hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda...Remote workRegulatoryMinimum wageFull timeLocal areaWorldwide- Takeda is seeking a Global Regulatory Labeling Strategy Lead for Plasma-Derived Therapies to drive strategic labeling across CCDS, US and EU labels while... ...experience and strong cross-functional collaboration. Remote work within the US is allowed, with a focus on global...Remote jobRegulatory
$290k - $350k
...Executive Director, Global Medical Affairs Lead - Oncology Reports to: SVP,... ...Medical Affairs Location: Remote Position Overview:... ...the global medical affairs strategy for our oncology portfolio... ...strategic objectives and regulatory requirements. The ideal candidate...Remote workRegulatory- Stealth Co is seeking a part-time Regulatory Affairs Consultant to guide global regulatory strategy for novel therapeutics. You will... ...regulatory and clinical plans, lead IND submissions, and plan FDA... ...environment. This role offers flexible remote/hybrid engagement in Cambridge,...Remote jobRegulatoryPart timeFlexible hours
- ...regenerates life in depleted soils globally with naturally occurring,... ...Summary: The Global Regulatory Affairs Lead is responsible for defining... ...Oath’s globalregulatory strategy to achieve and maintain "... ...Location: Home-based / Remote (USA-based preferred for proximity...Remote workRegulatoryContract workFor contractorsFor subcontractorWork at officeLocal areaWork from homeShift work
- Sarepta Therapeutics is seeking an experienced Regulatory Affairs professional to lead regulatory activities for clinical trials and product lifecycle across assigned markets. The role focuses on planning, submission reviews, and cross-functional collaboration to ensure...Remote jobRegulatory
$232k - $290k
...Revolution Medicines is a global, commercial-state... ...Medical Affairs (USMA) strategy and tactical plans with... ...gap assessments leading to the development/refinement... ...Business Development, Regulatory, Safety, and... ...preferred. #LI-VN1 #LI-Remote The base pay salary...Remote workRegulatoryFull timeLocal areaWorldwide- LivaNova is seeking a Regulatory Labeling & Operations Manager to own global labeling strategy for Neuromodulation therapies. You will drive compliant labeling across... ...Marketing and Operations. Responsibilities include leading EU MDR labeling initiatives, managing...Remote jobRegulatory
- Scorpion Therapeutics is seeking a Senior Regulatory Affairs leader to oversee global filings and compliance for a late-... ...marketing authorization. You will lead end-to-end submissions (BLA, MAA,... ...EMA, and MHRA to shape regulatory strategy for biologics and combination...Remote jobRegulatory
- Everforth Apex Systems is recruiting a Global Regulatory Lead to provide strategic regulatory leadership for a late‑stage cardiovascular development program, driving global strategies and NDA activities across multiple regions. The role requires leading cross‑functional...Remote jobRegulatory
- Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions, and FDA interactions. This role oversees US and international submissions and coordinates with global sites to ensure...Remote jobRegulatory
$258.68k - $313.46k
...careers of those who do it. Sr Director, Global Regulatory Strategy, Neuroscience Will be a key... ...regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned... ..., site-by-design, field-based and remote-by-design. The model assigned to this...Remote workRegulatoryHourly payFull timeSummer workLive inLocal areaFlexible hours$270k - $345k
...more regulated industries. Our global compliance program is bespoke, reflecting... ...and position as one of the leading AI labs operating on the frontier. Our Regulatory Programs pillar is a key pillar... ...program end to end: setting strategy and risk appetite with leadership...RegulatoryFor contractorsInterim roleWork at officeLocal areaRelocationVisa sponsorshipWork visaFlexible hours3 days per week- ...alternative application process. Global Controller - Remote - Boston Based Full-... ...: PharmaLogic is a leading global contract... ...with the highest quality and regulatory standards. Our rapidly expanding... ...in driving financial strategy and business performance....Remote workRegulatoryFull timeContract workLocal areaWork from home
- ...Executive Director, Global Medical Affairs Lead, Oncology About the Company... ...the global medical affairs strategy for the oncology portfolio... ...strategic objectives and regulatory requirements. This pivotal... ...environment. The position is remote and may require up to 20%...Remote workRegulatory
$192.4k - $302.39k
...ongoing optimization of the global medical strategy for zasocitinib in PsA, in... ...external scientific dynamics. Lead the global PsA Medical... ...recognizing local practice, access, regulatory, and stakeholder needs.... ...with Takeda’s Hybrid and Remote Work policy. Empowering...Remote workRegulatoryMinimum wageFull timeLocal areaWorldwide- ...Kabi USA, LLC seeks a Manager of Marketing Content Strategy for Cell & Gene Therapy Technologies. You will own global content strategies, translate complex scientific... ...will collaborate with Product Management, R&D, Regulatory, Legal, and Commercial teams to ensure content...Remote jobRegulatory
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