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
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Strategic CMC Reg Affairs Lead, Vaccines in Cambridge, MA vacancy
- ...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
- CRISPR Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience in CMC regulatory requirements for biologics and gene therapies...SuggestedRemote workFlexible hours
$137k - $215.27k
Takeda is seeking a Regulatory Affairs professional in Boston, MA to lead regulatory CMC initiatives for various pharmaceutical products. The role requires a minimum of 6 years of experience in regulatory CMC or related fields and a strong foundation in scientific principles...Suggested- BioSpace in Cambridge, MA is looking for a financial planning and analysis expert to lead CMC FP&A efforts. This role demands oversight of a $1 billion cost profile while providing decision-ready insights to senior leaders. The ideal candidate will possess over 5 years...Suggested
- Conditions. Workplace Diversity, LLC. is seeking a Senior Project Manager to oversee strategic initiatives and operational functions related to student engagement at Harvard University. Candidates must have a B.A. plus seven years of relevant experience, with a strong preference...
$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...$148.5k - $214.5k
...Job title CMC dossier leader Location : Framingham, MA About the... ...roles and responsibilities in leading the preparation of CMC dossiers... ...development and/or regulatory affairs. AI applications and prompt engineering. Core competencies: Strategic planning, time management,...Mass Digital Health
Cambridge, MA2 days ago- Aktis Oncology is seeking a dynamic Senior Manager to drive strategic outcomes within the CMC Operations organization. This role emphasizes project management, stakeholder engagement, and process optimization. The ideal candidate will have 5+ years in project management...
$117k - $184.2k
Merck is seeking a Promotion Manager for the U.S. Vaccines business unit, responsible for managing promotional resources and strategic development for the Contracting & Distribution team. This role involves collaborating with marketing and sales teams to ensure effective...Remote job- JobRx, Inc. is seeking an experienced MSL Team Lead to oversee a regional medical team. This role involves developing and implementing strategies while fostering relationships with Key Opinion Leaders in neurology and rare diseases. Exceptional leadership and scientific...
- Role Summary We are seeking an experienced professional to lead CMC analytical development as Aerska advances its siRNA programmes toward... ...operate effectively in a small-company environment, balancing strategic ownership with hands-on technical engagement as required....
$102.33k - $125.07k
...Inc. is seeking a Policy Manager in Government and Regulatory Affairs to provide analysis and advocacy on healthcare policy. This role... ...with various stakeholders to address pressing issues and develop strategic goals. The position, based in Boston, MA, offers a salary range...Flexible hours$165k - $180k
CRISPR Therapeutics in Boston is seeking an Associate Director of Regulatory Affairs CMC to lead the development of novel therapies. In this role, you'll guide cross-functional teams and ensure compliance with complex regulations. The ideal candidate will have extensive...- 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...
$120k - $150k
...decisions. Datavant is trusted by the world’s leading life sciences companies, government... ...For We are looking for an experienced Strategic Engagement Lead who thrives in a fast-... ...and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19,...$303k - $428k
...Therapeutics is seeking a Head of Nephrology to lead the development and execution of the US... ...primary medical contact, and providing strategic oversight for scientific content and... ..., or PharmD, with 12-15 years of Medical Affairs experience and 3+ years in Nephrology. Base...- Medical Affairs Lead, Global Rare Diseases - Contractor Department: GRD Global Medical Affairs Job Type: Contractor Business Area: Mktg... ...-rare disorders. Who we are looking for We are seeking a strategic and collaborative Medical Affairs professional to lead capability...Contract workTemporary workFor contractorsLocal area
- AstraZeneca in Boston seeks a Procurement Leader to manage strategic relationships and drive collaboration across business areas. The ideal... ...pharmaceutical sector, with a focus on marketing and medical affairs. The role involves developing a framework for Supplier...
- 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...
- Associate Director / Senior Manager, CMC Project Management Location Boston area preferred... ..., supporting RNA therapeutics, mRNA vaccines, and molecular diagnostics. With a vertically... ...solutions. Support projects with strategic partners in US. The candidate must have...Contract work
$137k - $215.27k
Initial Therapeutics, Inc. is looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device experience and a BS/BA degree in a scientific discipline. Responsibilities include executing regulatory...$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,...- ...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
$325k - $425k
...faster and more efficiently. About the Position The Medical Affairs Lead is a first-in-function leadership role responsible for... ...Sprifermin, in osteoarthritis. This leader will serve as a strategic scientific partner to Clinical Development, Regulatory, Commercial...Full timeWork at officeLocal areaRelocation3 days per week- A leading pharmaceutical company in Boston is seeking a Sr. Director of Medical Affairs to oversee medical strategies and ensure alignment with organizational goals. The candidate will lead a team, collaborate with various departments, and ensure compliance with industry...
- ...result, we are seeking an additional highly strategic and experienced Senior Regulatory... ...functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical... ...scientifically accurate communications Lead discussions on risk assessment and mitigation...
- ...oncology therapeutic area, leading regulatory efforts in... ...invent medicines and vaccines that treat and protect... ...nonclinical, clinical, CMC, commercial, and other... ...perspectives, providing strategic input on the Target Product... ...of relevant Regulatory Affairs experience in the...Local area
$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- ...deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Solid Tumors. About the role As a subject... ...publication and scientific communication strategic plan and deliverables for the assigned...For contractorsWork experience placementFreelanceLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Strategic CMC Reg Affairs Lead, Vaccines. Be the first to apply!
