Strategic CMC Reg Affairs Lead, Vaccines
Glaxosmithkline
GlaxoSmithKline in Cambridge, Massachusetts is seeking a Regulatory Affairs Manager to lead the Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for vaccines. This role requires expertise in FDA regulations, strong communication skills, and experience with regulatory submissions. The ideal candidate will possess a bachelor's degree in life sciences and at least 2 years of relevant experience. This position offers a hybrid work model, requiring regular onsite presence. #J-18808-Ljbffr GlaxoSmithKline
- ...focuses on discovering and delivering vaccines and medicines, combining our... ...thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution... ...years of experience in CMC regulatory affairs mainly in the U.S., with a focus...SuggestedLocal area
- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Suggested
$148.5k - $214.5k
...Job title : CMC dossier leader ~ Location: Framingham... ...responsibilities in leading the preparation of CMC... ...invent medicines and vaccines that treat and protect... ...development and/or regulatory affairs AI applications and... ...Core Competencies: Strategic planning, time...Suggested$204k - $292k
Repertoire-Immune-Medicines is seeking a Vice President, Head of CMC in Cambridge, MA. This role involves leading all CMC activities for protein biologics, establishing CMC strategy, and managing external partnerships. Candidates must have a PhD and 15+ years in biotechnology...Suggested- ...Medical Communications team. This hybrid role involves leading client relationships of ~$2M, providing strategic counsel, and ensuring high-quality deliverables for... ...candidate should have over 6 years of medical affairs experience, with a focus on emerging biotech clients...Suggested
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- Job Title CMC Lead, Launch Product, Small Molecules Locations Zurich, Switzerland (Primary); Cambridge, MA (Secondary) About The Role... ...a CMC Lead, Launch Product, Small Molecules, you will provide strategic and operational leadership for the CMC execution and lifecycle...Full time
- Job Title: CMC Demand & Supply Leader Location: Framingham, MA... ...enables us to invent medicines and vaccines that treat and protect... ...lives. Main Responsibilities Lead collaborative work with Global... ...associated risks and costs to support strategic project decisions and budget...
- Eacademy Sanofi is seeking a Scientific Fellow, AI-Enabled CMC, who will contribute at the intersection of AI, computational science, and Chemistry, Manufacturing, and Controls. The role demands expertise in shaping scientific strategies and leadership on integrating AI...
- Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs CMC Development in Cambridge, MA. In this hybrid position, you will be responsible for implementing the global regulatory CMC strategy, shaping regulatory strategies for innovative modalities like oligonucleotide...
- ...A leader to drive budgeting, forecasting, and reporting for its CMC function. You will partner with Corporate FP&A and CMC Accounting... ..., scenario analysis, and executive-grade reporting to guide strategic decisions in a fast-paced biotech environment. #J-18808-Ljbffr...
- ...Executive Director, Global Medical Affairs Disease Area Lead, Solid Tumors About the Company Rapid-growing life sciences & biotechnology... ...clinical solid tumor oncology. The ideal candidate will have a strategic leadership approach, be results-driven, and possess...Flexible hours
$170k - $220k
WHOOP is looking for a Staff Regulatory Affairs Associate to shape the regulatory strategy for digital health and AI-enabled technologies... ...a primary advisor to cross-functional teams on compliance and strategic guidance. The ideal candidate will have a Bachelor’s degree,...$169.4k - $266.2k
...deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Solid Tumors. As a subject matter expert... ...publication and scientific communication strategic plan and deliverables for the assigned oncology...Minimum wageFull timeFor contractorsWork experience placementFreelanceLocal areaRemote work- ...Athenahealth is seeking a Senior Associate in Procurement to drive strategic sourcing initiatives in Boston. The role involves developing sourcing strategies, managing vendor relationships, and ensuring effective procurement processes. With a hybrid work arrangement, the...
- ...Global Atopic Dermatitis Medical Lead Location: Cambridge, MA /... ...Medical Franchise, driving strategic initiatives and innovation in... ...us to invent medicines and vaccines that treat and protect millions... ...develop an aligned medical affairs plan to support the brand strategy...Worldwide
- Datavant is seeking an experienced Senior Strategic Engagement Lead to handle a dedicated account portfolio within the biopharma segment in Boston, MA. The role demands ensuring customer satisfaction and enhancing value realization for our clients. Key responsibilities...
- Boston University is seeking an Assistant Director of External Affairs to strengthen CARB-X’s financial sustainability and partnerships in the global antimicrobial innovation ecosystem. This role involves managing relationships with funders and policy-makers, drafting funding...Remote job
$90k - $119k
We are seeking an experienced Engagement Manager to lead managed services engagements for healthcare organizations leveraging InterSystems... ...outcomes. This is not a project management role. It is a strategic ownership role that combines relationship leadership,...Contract workTemporary workWorldwide$202.5k - $337.5k
Global CMC Automation and Robotics Leader 2 weeks ago Be among the first 25 applicants... ...and humanoid robots across CMC Build and lead a team of advanced automation & robotics... ...of vendor alignment, Capex preparation, strategic workforce hiring, and alignment on automation...Full timeLocal area$112.1k - $225.5k
...LLP is seeking an experienced professional in Boston, MA, for a strategic finance role focused on financial planning and analysis. The... ...over 6 years of relevant experience. Responsibilities include leading consulting engagements, managing teams, and developing financial...Flexible hours- ...seeking a Senior Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position involves supporting regulatory... ...ability to navigate complex regulatory frameworks. You will lead global regulatory submissions and collaborate with cross-functional...
- Takeda is seeking an Associate Director for Scientific & Competitive Analysis in Boston, MA. This role involves providing strategic insights to both Commercial and R&D teams, ensuring competitive leadership through detailed market analysis and brand planning. The ideal...
- A global pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and managing all assigned programs while ensuring compliance with advertising and promotion regulations. Candidates should...Remote work
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$93k - $147k
Full-Time Sr. Strategic Sourcing Lead, Marketing Hybrid, Boston, MA. You will lead strategic sourcing and category management efforts that drive commercial growth and profitability. In this role, you’ll partner closely with stakeholders and suppliers to optimize costs,...Full timeContract workWork at office- Takeda Oncology in Boston, MA seeks a Lead, Contract Management to oversee end-to-end contracting for pricing, value, and access programs... ...high‑quality Market Access agreements, ensuring compliance and strategic alignment. The role emphasizes governance, risk assessment, and...Contract work
$160k - $180k
Addgene USA is seeking a Business Development Lead based in Watertown, Massachusetts to shape and execute our business development... ...The role involves leading high-value negotiations and managing strategic partnerships with key academic and industry stakeholders. Candidates...
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