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
$195k - $330k
...make an impact:Act as the global regulatory strategy lead for Kymera’s IRF5 degrader... ...to program teams and senior leadership.Manage and support junior... ...degree preferred but not required.Director: 8-10 years of Regulatory Affairs experience. Senior Director: 10-12...SeniorFlexible hours$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$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$163.5k - $281.6k
...us. Responsibilities Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including... ...mitigation strategies and providing strategic recommendations to senior leadership. Stay current with evolving global regulatory requirements...SeniorFull timeFor contractorsWork at officeFlexible hours$163.5k - $281.6k
...matters for patients, we invite you to join us. Eli Lilly and Company is seeking a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting‑edge gene therapy portfolio. This role will be critical...SeniorFull timeFor contractorsWork at officeFlexible hours$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$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- Title: Director / Senior Director, Global Regulatory Lead Location: San Francisco, CA or Boston, MA -> hybrid 3-days per week (relocation offered!) Overview... ...(PhD, PharmD, MS) preferred 10+ years of regulatory affairs experience within biotech/pharma Recent, hands-on...SeniorRelocation3 days per week
- Senior Manager - Regulatory Affairs Operations Location - Cambridge, MA (Hybrid) Oncology Biotech | Global Clinical Programs I’m currently supporting... ...regulatory submissions. The Role Reporting into the Director of Regulatory Affairs Operations, you will provide hands...Senior
$242k - $313.5k
Senior Director, Regulatory Affairs CMC - Biologics About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and...SeniorLocal area2 days per week$258.3k - $387.5k
...must be eligible to work in the US. Your Role The Senior Director manages a team of promotional regulatory professionals in the review and approval of U.S. promotional... ...dissemination of actionable insights to Regulatory Affairs teams, review committees, and cross-functional...SeniorWork at officeFlexible hours3 days per week- Job-ID32387836Reference26-00886 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...Senior
$259k - $317k
...and empowered to make an impact — both within our company and in the lives of patients we serve.Position Summary:The Senior Director of Regulatory Affairs is a senior leader responsible for developing and executing global regulatory strategy across the product portfolio....SeniorFull timeWork at officeFlexible hours- ...The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and... ...The Reg Nonclinical / Clinical Associate Director will lead, conceive, communicate and execute... ..., influence and negotiate with senior Nonclinical / Clinical leaders on product...Senior
$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$245k - $300k
...Sr. Director, Regulatory Affairs At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically... ...Biosciences is seeking an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global regulatory...SeniorLocal area- ...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
$195k - $330k
...the development and execution of global regulatory CMC strategies for degrader programs across... ...strategic regulatory CMC guidance to senior leadership regarding health authority interactions... ...readiness.Scale and lead the Regulatory Affairs CMC function as the pipeline and...Senior$196.7k - $353.4k
The RoleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and...SeniorPermanent employmentFull timeWork at officeWork from home- ...$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
$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- 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
- Regulatory Affairs CMC, Manager/Senior Manager Currently partnering with a public Biotech who are currently expanding and seeking an experienced Regulatory CMC Manager to support the global development and registration of biologic products across all stages of the product...Senior
$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- Beeline Medicines Corporation is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead the CMC regulatory strategy for monoclonal antibodies and other large molecules. You will drive submissions, interact with FDA/EMA, and align cross‑functional teams across...Senior
- ...-accepted standards like GxP, ISO 9001, and 21 CFR Part 11. As Senior Compliance Manager, US, you will operate as an independent senior... ...for ensuring TetraScience's products and platform meet the regulatory expectations of the world's largest pharma and biotech customers...SeniorImmediate startFlexible hours
- Vor Bio seeks an exceptional and highly motivated Director/Sr Director Regulatory CMC to lead development and implementation of robust regulatory CMC strategies across programs and lifecycle stages to support telitacicept through clinical development and global registration...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
- ...Staffing is assisting in the search for a Compliance Director - Private Equity (Credit Investment Funds)... ...advising on co-investments, affiliated transactions, and regulatory considerations while reporting to senior leadership and the board. #J-18808-Ljbffr Origin StaffingSenior
- Rhythm Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-quality, compliant CMC deliverables... ...individual contributor role collaborates with Global Regulatory Affairs, Technical Operations, and Quality to ensure timely, complete...Senior
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