Vaccines CMC Regulatory Strategy Lead
NCBiotech
NCBiotech in Durham, North Carolina is seeking a Regulatory Affairs professional to lead Chemistry, Manufacturing, and Controls (CMC) for vaccines. You will ensure compliance with FDA regulations and manage regulatory submissions. The role requires collaboration with cross‑functional teams to ensure product lifecycle management and innovation. The ideal candidate will have a Bachelor's degree in a relevant field and over two years of experience in CMC regulatory affairs. This position offers a hybrid working model as well as competitive salary and benefits associated with the role. #J-18808-Ljbffr NCBiotech
- ...Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the... ...the right thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects in the...RegulatoryLocal area
- GlaxoSmithKline in Durham, North Carolina, seeks a CMC Regulatory Lead to oversee regulatory strategies for vaccine projects. The role involves collaboration with cross-functional teams to ensure compliance with FDA regulations and to prepare comprehensive regulatory submissions...Regulatory
- NCBiotech is looking for a key leader to support Chemistry, Manufacturing and Controls (CMC) regulatory strategy. This role involves ensuring timely access to medicines through the management of complex CMC regulatory processes. The successful candidate will have a Bachelor...Regulatory
$144.38k - $240.63k
.... Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the... ...of disease together. Position Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities. You...RegulatoryWork at officeLocal areaRemote workWorldwide- GlaxoSmithKline is seeking a Principal Medical Writer in Durham, NC to lead medical writing for complex clinical and regulatory projects. The ideal candidate will have 5+ years of experience in the pharmaceutical industry and a Bachelor's degree in life sciences. This...Regulatory
- GlaxoSmithKline in Durham, North Carolina is seeking a Principal Medical Writer to lead regulatory document preparation for complex clinical projects. This role demands excellent communication skills and a strong background in medical writing, with a focus on HIV-related...RegulatoryRemote job
- ...This role involves embedding information security into business strategy and product delivery. Key responsibilities include advising... ...cybersecurity strategies. Strong engagement skills and knowledge of regulatory compliance are required. #J-18808-Ljbffr Syneos Health, Inc.Regulatory
$195.75k - $326.25k
...Strategic Engagement & Portfolio/Pipeline Strategy leads the integrated U.S. commercial strategy... ...in compliance with policies, SOPs, and regulatory requirements.Proactively manage risk... ...innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory...RegulatoryLocal area- ...information, visit JOB SUMMARY We are seeking a Senior Director, Head of Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. This role will lead strategy, compliance, and submissions for complex manufacturing processes...RegulatoryTemporary workLocal areaVisa sponsorship
$190k - $260k
Shattuck Labs, Inc. is seeking a Director (Senior Director), Regulatory Affairs in Durham, NC. This role requires a minimum of 8 years... ...pharmaceutical industry and involves overseeing global regulatory strategies for drug development. The successful candidate will manage...Regulatory- Alcon is seeking a Sr. Associate II, Regulatory Affairs Strategy to ensure compliance for innovative intraocular devices. This onsite role includes coordinating regulatory submissions, conducting independent research, and driving competitive advantage through regulatory...Regulatory
- Position Summary You will lead planning, compilation, and delivery of regulatory submission dossiers for investigational and lifecycle activities in the United... ...work closely with global submission teams, clinical, CMC, quality, publishing, and local regulatory partners....RegulatoryWork at officeLocal areaRemote work
$114.1k - $211.9k
If you’re driven to lead complex projects and ensure world‑class commissioning and qualification... ...the highest standards of quality and regulatory compliance. You will lead both project... ...and commissioning and qualification strategies end‑to‑end, partnering across teams to...RegulatoryLocal areaWorldwideRelocation package- ...BIM, Standards & Document Control Program Lead to join the Facilities Business... ...traceability, and compliance with corporate and regulatory requirements. Define and enforce BIM... ...alignment with Wolfspeed’s global growth strategy. Qualifications Bachelor’s degree in Civil...Regulatory
- Responsibilities: Lead and manage clinical data management activities for oncology... ...plans in alignment with study protocols and regulatory requirements. Oversee the design,... ...to ensure alignment of data management strategies with overall clinical development goals....RegulatoryWork at officeRemote work
$110k - $155k
...is initiating a search for a Full-time a Lead - Commissioning for our Raleigh, NC... ...requirements, load calculations, and operating strategies to account for the proper installation... ..., compliance documentation, and regulatory and technical analysis memos. Coordinate...RegulatoryFull timeFor subcontractorWork at officeLocal areaFlexible hours- ...Overview Role: Lead Registered Dietitian Join Healthcare Services Group (HCSG)... ...residents, families, and staff. Knowledge of regulatory requirements and best practices in... ...data, etc. Compliance with COVID-19 Vaccination Policies, as required by State, Local, and...RegulatoryFull timeLocal areaShift workDay shift
- ...Therapeutics, Inc. in Morrisville, North Carolina is seeking an experienced Medical Writer to develop and manage high-quality clinical, regulatory, and scientific documents. This role involves close collaboration with cross-functional teams in a biotechnology environment. The...RegulatoryFull timeContract work
- ...content#Senior Manager, University Talent Insights & Strategy page is loaded## Senior Manager,... ...Talent Insights and Strategy to lead how we use insights and structure to strengthen... ...rules and regulations of numerous self-regulatory organizations, including FINRA, among...Regulatory
- ...Description WSP USA is initiating a search for a Lead Geologist for the Greensboro, North... ...be a significant contributor both with strategy and delivery on a team providing project... ...and State (NC, SC, VA) environmental regulatory programs. Highly effective interpersonal...RegulatoryContract workFor subcontractorWork at office
$147.9k - $200k
...adhere to our compliance standards and regulatory requirements. This position will focus on... ...compliance programs. You will report into the Lead Ethics & Compliance International based... ...risks. Develop and implement strategies to mitigate identified risks. Design and...RegulatoryFull timeWork at officeLocal areaWork from homeWorldwide3 days per week$93.5k - $121k
...difference in the lives of our patients and customers. Are you ready to join us? Alcon is looking to hire a Sr. Associate II, Regulatory Affairs Strategy . This role is part of Alcon's Quality & Regulatory Affairs function—a critical organization responsible for ensuring our...RegulatoryRelocationFlexible hours- ...Opportunity WSP is growing, and we have opportunity for a Lead Environmental Scientist to support our Charlotte,... ..., and Local environmental laws, policies, and regulatory requirements. Support the overall long‑term strategy, growth, and pipeline development of Environmental...RegulatoryContract workFor subcontractorWork at officeLocal area
- IQVIA Argentina is seeking a Principal for COA Strategy Consulting to lead client projects and business development in a collaborative environment. This role involves developing strategies for complex client needs and mentoring team members. The ideal candidate has over...
$130k - $180k
A leading consulting firm is seeking a Sr. Consultant for Master Data Management to oversee MDM implementations for clients in the pharmaceutical... ...act as a trusted advisor to clients, ensuring successful data strategies and implementations. Competitive compensation includes a...Flexible hours- ...Responsibilities Will Be Responsibilities (Enterprise Platform Strategy Ownership) Define the CX360 Strategic Vision: Establish the long... ...CX360 use case prioritization and business requirement clarity. Lead Platform Architecture Understanding: Define how CX360 integrates...Temporary work
- ...US medical analytics team. This role involves synthesizing complex datasets into actionable insights to inform decision-making for Vaccines/AIR Medical Affairs. The ideal candidate will have 5+ years of experience in healthcare analytics, proficiency in AI, and strong...
- ...insights that support cross-functional medical affairs stakeholders, impacting the effectiveness of data-driven decisions within GSK's Vaccine & AIR portfolio. The ideal candidate will leverage AI and advanced analytics to enhance insight discovery, demonstrating a strong...
- ...Healthcare in Durham, NC is seeking a Statistical Leader to manage medium-scope projects and guide study strategy. You will be accountable for scientific integrity and lead cross-functional teams, while fostering strong networks within the scientific community. The ideal...
- Labcorp is seeking a Senior Lead Biostatistician - Oncology Evidence Generation to join... ..., driving study design, analytical strategy, and execution to ensure high‑quality, scientifically... ...with clinical study documentation and regulatory standards (e.g., protocols, SAPs, GCP...RegulatoryTemporary workCasual workMonday to FridayFlexible hoursDay shift
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