Senior Director, Regulatory Affairs
EMD Serono
EMD Serono, Inc. is seeking a Senior Director to lead a team in regulatory review of promotional materials for U.S. prescription drugs. This role ensures compliance with FDA regulations and shapes the regulatory strategy across multiple therapeutic areas. The ideal candidate will have a strong background in the pharmaceutical industry, with at least a Bachelor's degree in a science-related field and a minimum of 10 years of relevant experience. Position offers a hybrid work model based in Boston, MA. #J-18808-Ljbffr
$275k - $315k
Position OverviewBicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the VP, Regulatory Affairs, you will serve as the primary US regulatory...SeniorFull timeTemporary workWork at officeLocal area3 days per week- ...is a Boston-based biopharmaceutical company seeking a Senior Director, US Regional Regulatory Lead to shape US regulatory strategy and lead FDA interactions... .... The role requires 12+ years in Regulatory Affairs, leadership experience, and a strong background in oncology...SeniorRemote work
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$200k - $220k
...Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first‑and potentially best‑in‑class dual BAFF/APRIL...SeniorContract workWorldwideFlexible hours$183.55k - $275.32k
...Director/Sr. Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Who we are: At... ...readiness. Act as a trusted advisor to senior leadership on promotional risk and... ...+ years of experience in Regulatory Affairs within the biopharmaceutical...SeniorTemporary workLocal areaRemote workWork from homeFlexible hours3 days per week$220k - $290k
...innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to... ...the Corporation’s short and long‑term plans. The Senior Director, Regulatory Affairs has foresight, is action oriented, a problem‑solver, is...SeniorTemporary workFor contractorsWork at officeWeekday work$238k - $294k
...Sr. Director, Regulatory Labeling and Advertising Promotion About Genetix Biotherapeutics At Genetix... ...to Clinical Development, Medical Affairs, Commercial, Legal, and Safety, and plays... ...authority and partner effectively with senior leaders. Strong attention to detail and...SeniorFull timeWork at officeFlexible hours3 days per week- The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring... ...Reg Nonclinical / Clinical Associate Director will lead, conceive, communicate and... ..., influence and negotiate with senior Nonclinical / Clinical leaders on product...Senior
- Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: This role is within in the GRA Chemistry Manufacturing...Senior
$145k - $215k
...you’ll make an impact:Kymera Therapeutics is seeking a Senior Manager, Regulatory Affairs to serve as a key regulatory contributor and emerging strategic... ...multiple drug development programs. Reporting to the Director of Regulatory Affairs, the Senior Manager will...Senior$137k - $215.27k
...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide- ...years professional experience in legal, regulatory, compliance environments; attorneys with... ...actionBuilds trust-based relationships with senior leaders within and outside of the team;... ...managing concerns.Your role reports to the Director of Ethics in Allegations Management.SeniorApprenticeshipWork at office
$245k - $300k
...paradigms across the spectrum of antibody-driven diseases. Merida Biosciences is seeking an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global regulatory strategies across our development programs. This individual will serve as a key...SeniorLocal area$272.57k - $327.09k
...to win, and supports your development at every step. The Senior Director, Global Regulatory Strategy will be responsible for providing senior... ...Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight,...SeniorFull timeTemporary workWork at office3 days per week$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for... ...senior management on status of global Regulatory Affairs strategies and tactics, procedures and practicesLeads the...SeniorFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$240k - $320k
...unparalleled, direct impact.The OpportunityThis role leads US regulatory policy and advocacy efforts to support the advancement and lifecycle... ...topic areas.Liaise with other GRA staff, US government affairs staff, R&D functions, and other internal stakeholders to support...SeniorFull timeTemporary workWork experience placementWork at officeWorldwide- ...$170kJob Description An established organization is seeking a Senior Compliance Manager to support and drive compliance initiatives... ...processes, systems, and operations align with industry standards and regulatory requirements. This hands on position partners with cross...SeniorFlexible hours
- ...EY is seeking a Senior Manager for its Life Sciences Regulatory Submissions practice based in Boston. This role focuses on driving growth and establishing EY as a leader in regulatory compliance. The ideal candidate will have extensive experience in regulatory submissions...Senior
- ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...Senior
$280k - $320k
Role Overview & Key Functions:The Regulatory Science Lead is responsible for advancing and applying regulatory science to all our regulatory... ..., Clinical Pharmacology, Medical Writing, and Regulatory Affairs teams to ensure the Company’s regulatory submissions are cohesive...SeniorFull time- Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission...SeniorFull timeRemote work
$212k - $333.19k
...a lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...such as understanding broad concepts within regulatory affairs and implications across the organization and globally;...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide$270k - $350k
The Senior Director, Regulatory Affairs is responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for small molecule programs across early and late-stage development to support global regulatory approvals. This...SeniorShift work$251.77k - $307.72k
...More:We are seeking an experienced QMS and Digital Compliance Senior Director to lead transformational change within our quality... ...comprehensive global QMS governance framework ensuring compliance with regulatory requirements, industry standards, and company...SeniorFull time$170k - $240k
Litigation Marketing Senior Manager - RegulatoryCooley is seeking a Litigation Marketing Senior Manager - Regulatory to join the Marketing team.Position summary: The Senior Practice... ..., under the supervision of the Associate Director or Director of Marketing (Business/...SeniorFull timeTemporary workWork at officeImmediate startFlexible hoursWeekend work- ...Senior Vice President, Head of Compliance About the Company Accomplished provider of personal loans & related services... ...Officer, and oversee all aspects of compliance, including managing regulatory exams, audits, and reporting. The role also involves collaborating...Senior
$247.2k - $334.4k
The Senior Legal Director, R&D and Regulatory Counsel is a strategic legal leader who enables efficient, high-quality decision-making on regulatory pathways... ...counsel to cross-functional partners across Regulatory Affairs, Public Policy & Government Relations, Therapeutic Area...SeniorFull timeTemporary workLocal areaFlexible hours- ...clients seeking world-class professional resources.Job DescriptionUS Regulatory Advertising and Promotion (US Reg AD/Promo) is responsible for... ...according to EEO guidelines.SummaryType: ContractFunction: ManagementExperience level: Mid-Senior LevelIndustry: PharmaceuticalsSeniorFor contractors
- Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development... ...as representative of Global Regulatory Affairs at project team meetings with both external... ...Regulatory experience required for the Senior Manager Regulatory level. Candidates must...SeniorFlexible hoursNight shift
$113.15k - $270.02k
...standardized processes and grow with a team that is not afraid to push the status quo.KPMG is currently seeking a SALT Direct Tax Senior Manager, Shared Services to join our Delivery Center.Responsibilities:Work in our compliance center of excellence to support engagement...SeniorWork at officeLocal area
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