Regulatory Strategy Lead — US & Canada
BioSpace
AbbVie in the United States is seeking a Senior Manager Regulatory Affairs to lead regulatory strategy for US and Canada, ensuring timely submissions and compliance across therapeutic areas. The role requires collaboration across Regulatory, Clinical Development, Legal, and Commercial teams. The position supports a hybrid work schedule with in-office and remote days and will operate from major US sites including Cambridge, MA, Lake County IL, Florham Park NJ, or Irvine CA as needed. #J-18808-Ljbffr BioSpace
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Strategy Lead — US & Canada in Cambridge, MA vacancy
- AbbVie is seeking a Senior Manager Regulatory Affairs to lead Global Regulatory Strategy for US & Canada. You will shape regulatory plans for on-market and development products and ensure compliance with US/Canada requirements, coordinating with global teams. You will liaison...Regulatory
- AbbVie's Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada, is responsible for developing and implementing regulatory strategy for US and Canada, ensuring alignment with GRPT and regulatory requirements. The role interfaces with FDA and coordinates submissions...Regulatory
- AbbVie Inc. in the United States seeks a Senior Manager Regulatory Affairs to lead regulatory strategy for US & Canada, ensuring alignment with GRPT and business needs. You will gather data to support filings and enable commercialization while liaising with Health Authorities...Regulatory
$124.5k - $236.5k
Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada Full-time Salary Min: 124500 Salary Max: 236500 Workday Global Grade: 19 Compensation: USD... ...Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the...RegulatoryFull timeWork at officeRemote work- Alnylam seeks an Associate Director of Regulatory Affairs Strategy to lead regulatory strategy for early programs, coordinate submissions, and oversee US interactions with health authorities. The role requires cross-functional collaboration, multidisciplinary team involvement...Regulatory2 days per week
- Keurig Dr Pepper seeks a Manager, HR Compliance to lead compliance strategy across the U.S. and Canada, including governance, policy development, and risk... ...mitigation. This role partners with Legal Counsel, audits, regulatory reporting, HR policy development, and employee...Regulatory
- 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...RegulatoryRemote job
- ...in Cambridge, MA seeks an Associate Director to define and lead global regulatory strategies for complex programs, providing strategic and tactical... ...FDA and global regulatory requirements. The role oversees US FDA submissions, stakeholder communications, and staff mentorship...Regulatory
- Takeda is seeking a Global Regulatory Labeling Strategy Lead for Plasma-Derived Therapies to drive strategic labeling across CCDS, US and EU labels while coordinating with internal stakeholders to ensure regulatory compliance and successful product evolution. This role...RegulatoryRemote job
- ...Therapeutics is seeking a Senior Director, Brand Lead – US who will be responsible for developing and executing the US brand strategy and commercial plan for ficerafusp alfa,... ...programs Partner with Medical Affairs, Regulatory, Legal/Compliance, Market Access,...RegulatoryWork at officeLocal area3 days per week
- Sanofi in the US seeks a senior medical leader to head the One... ...will build and execute medical strategy across Rare Disease and Rare Blood... ...healthcare systems. You will lead talent, budget, and... ...decisions, and ensure compliance with regulatory standards while partnering with...RegulatoryHome office
$155k - $213.5k
...the recruiter directly. About This Role The US Lifecycle Management Lead is a senior individual contributor accountable for... ...launches are supported by robust supply, quality, regulatory, and flow‑of‑goods strategies. You will partner closely with Asset Leaders and...RegulatoryFull timeTemporary workLocal area- Job title: US Neurology and Immunology Asset/Indication Lead Location: Cambridge, MA About The Job Sanofi's specialty... ..., value-based contracting strategies, etc. Set HEOR evidence generation... ...Neurology and Immunology launch assets Regulatory & Compliance Knowledge Apply...RegulatoryContract work
- ...Job Description Strategy Lead, Business Strategy \n \n MassMutual is a Fortune 100 financial... ...industry trends, competitive dynamics, regulatory developments, emerging technologies, and... ...the application process, please contact us and share the specifics of the...RegulatoryTemporary work
- ## Senior Director, US Market Access Strategy, Povetacicept (POVE)Applylocations: Boston, MAtime type:... ...Director, US Market Access Strategy to lead market access initiatives for **... ...’t and commercial payers, policy, and regulatory environment* Pharmacy and medical benefit...RegulatoryContract workSummer workRemote workRelocationFlexible hours2 days per week3 days per week
- ...applicable law. Job Purpose The Director – US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs is responsible for leading the CMC Regulatory Affairs team with a... ...management, and post-approval regulatory strategy for FDA and internationally approved...Regulatory
$109.24k - $163.87k
...Reports to: Senior Director, Global Regulatory Strategy About Alexion For over 30 years, Alexion... ...of people living with rare diseases. We lead with breakthrough science, deep disease... ...The Senior Manager, Regulatory Affairs US lead will be responsible for leading,...RegulatoryTemporary workWork at office- Sanofi's HEVA team in Cambridge, MA is seeking a Systemic Mastocytosis/Emerging Indication HEOR Strategy Specialist to lead US-focused HEOR for AYVAKIT and new assets. You will design economic models, conduct RWE studies, and prepare payer dossiers to support US access...
$177k - $278.08k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program... ...solutions. Accountable for all US FDA submissions and approvals of... .... Knowledge of FDA, EU, Canada, ROW and post-marketing a plus....RegulatoryMinimum wageFull timeLocal areaRemote work- The Director, Medical Strategy - Rare Emergency Medicine will serve as a key member of the US Medical team, responsible for developing... ...Development, Commercial, Regulatory, Market Access, and other key... ...commercialization and post-marketing. Lead efforts to seek expert...RegulatoryImmediate start
$177k - $278.08k
...Takeda as a Director, Global Regulatory Lead Oncology where you will be part... ...will set global regulatory strategy and lead major submissions for... .... Accountable for all US FDA submissions and approvals... ...is a must. Knowledge of EU, Canada, ROW is a plus. Experience...RegulatoryMinimum wageFull timeLocal areaRemote workWorldwide- Stealth Co is seeking a part-time Regulatory Affairs Consultant to guide global regulatory strategy for novel therapeutics. You will advise leadership and work with... ...internal teams to align regulatory and clinical plans, lead IND submissions, and plan FDA interactions in a...RegulatoryRemote jobPart timeFlexible hours
- Scholar Rock is seeking an Associate Director, Regulatory Strategy in the greater Boston area to lead the development and execution of regulatory plans for clinical and pipeline programs. This role represents regulatory affairs on cross-functional teams and directs submissions...Regulatory
- ...Inc. seeks a senior Business Engagement Lead to partner with Clinical Development and... ...role emphasizes stakeholder management, regulatory compliance, and collaboration with product... ...enable faster submissions and better outcomes for patients. #J-18808-Ljbffr Jobleads-USRegulatory
- ClinLab Solutions Group in Watertown, MA is expanding its regulatory capacity. The Global Regulatory Lead will take ownership of regulatory strategy and execution for an assigned program, reducing reliance on external consultants and closing timeline gaps created by competing...Regulatory
- Takeda is seeking a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will serve as GRL on GPTs, coordinate with global teams, and ensure FDA submissions and other major filings...Regulatory
- ...biopharma company focused on muscle biology, is seeking an Associate Director, Regulatory Strategy in the greater Boston area. You will shape regulatory strategy for clinical and pipeline programs and lead agency communications to advance anti-myostatin therapies and other...Regulatory
- Draper is seeking a Treasury Manager in Cambridge, MA to lead the Treasury function, supervise the Treasury Analyst, and oversee... ...internal teams and external providers to support financial strategy and regulatory reporting. The ideal candidate has 5-7 years of progressive...Regulatory
- Sarepta Therapeutics is seeking a Global Regulatory Lead to drive high quality regulatory documents (INDs, CTAs, NDAs) and lead interactions... ...periodic international meetings. You will craft regulatory strategies, ensure compliance, and guide teams through FDA engagements,...Regulatory
- ...Derived Therapies Procurement to lead end-to-end sourcing, category strategy, and supplier relationships... ...programs, optimize total cost of ownership, and ensure compliance with regulatory standards across equipment, services, and real estate. #J-18808-Ljbffr Jobleads-USRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Strategy Lead — US & Canada. Be the first to apply!
Related searches
- regulatory executive Cambridge, MA
- regulatory Cambridge, MA
- regulatory law Cambridge, MA
- regulatory technician Cambridge, MA
- regulatory scientist Cambridge, MA
- food regulatory Cambridge, MA
- regulatory cmc Cambridge, MA
- clinical research regulatory Cambridge, MA
- regulatory engineer Cambridge, MA
- regulatory contract Cambridge, MA




