Global CMC Scientist: Regulatory Strategy & Submissions
UCB
UCB is seeking a Regulatory CMC Scientist to join the Global Regulatory team in Raleigh, North Carolina, or other offices. The role entails defining strategy and preparing CMC submissions for regulatory approvals, working closely with technical and regulatory teams. Qualified candidates should have a Bachelor's or Master's in life sciences or business, significant experience in Regulatory Affairs CMC, and effective communication skills. UCB is an equal opportunity employer. #J-18808-Ljbffr UCB
- We are looking for a Regulatory CMC Scientist to join us in our Global Regulatory team, based in any of our Brussels (Belgium... ...offices. About The Role Define the strategy, planning and preparation (writing and review) of CMC submission documentation for regulatory...Regulatory
$150.03k - $224.25k
...America Pharmaceutical Inc. is looking for a CMC Regulatory Strategist in Raleigh, NC. This role involves providing regulatory strategies for investigational and marketed biologics... ...small molecules, ensuring compliance with global regulatory standards. Candidates should...Regulatory- Azurity Pharmaceuticals - US is seeking a Vice President, Global Head of Regulatory Affairs to lead global regulatory strategy and execution across a diverse portfolio. The ideal candidate will have 15+ years in Regulatory Affairs, a strong leadership background, and expertise...Regulatory
- A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global regulations. The ideal candidate has 5-10 years of experience in Regulatory CMC, a strong technical background in relatorette...RegulatoryRemote job
$150.03k - $224.25k
Job Summary Provide CMC regulatory strategy input and expertise in the area of investigational, new... .../maintained in compliance with global regulatory requirements and guidances... ...requirements for CMC and GMP related submissions and inquiries. Represents CMC RA in...RegulatoryContract workTemporary workWork at officeLocal areaFlexible hours- Join Azurity Pharmaceuticals in Raleigh, NC as the VP, Global Head of Regulatory Affairs. In this role, you will lead regulatory strategies, ensuring compliance and timely submissions. Candidates should hold an MD, PhD, or PharmD and have over 15 years of experience in...Regulatory
- ...include some of the industry’s top scientists, clinicians, business strategists,... ...happier lives. Job Summary The , CMC Global Regulatory Affairs is responsible for leading... ...development of CMC and device regulatory submission strategies by working closely with colleagues...RegulatoryContract workRemote workShift work
- RHO in North Carolina is seeking a CMC Regulatory Strategist to lead and provide regulatory support for interdisciplinary pharmaceutical programs. The ideal candidate will have a PhD/PharmD and at least 12 years of relevant experience, particularly with FDA regulations...Regulatory
- ...seeks an accomplished Vice President of Clinical Development to lead the global clinical development strategy and execution across all phases. You will shape portfolio direction, ensure regulatory readiness, and drive high-impact decisions with senior leadership. You will...Regulatory
- ...company based in North Carolina is seeking a Director for CMC Global Regulatory Affairs. This role is responsible for overseeing all regulatory... ...industry along with a strong background in regulatory strategies and FDA compliance. A competitive compensation package is offered...RegulatoryRemote job
- Azurity Pharmaceuticals seeks a Regulatory Affairs Associate/Senior Associate to assist in... ...submitting regulatory filings to the FDA and global agencies. You will contribute to... ...and Medical Affairs to ensure compliant submissions and timely regulatory decisions while maintaining...Regulatory
- Piper Companies is seeking a Regulatory Affairs Specialist I - CMC to support our end client's Chemistry, Manufacturing, and Controls (CMC) Regulatory... ...candidate will manage CMC regulatory documents and submissions, requiring 2-3+ years of experience in the pharmaceutical...Regulatory
$118k - $147.5k
...) group is seeking a Senior Scientist with deep expertise in biologics... ...Manufacturing, and CMC Drug Substance/Drug Product... ...development and enable downstream CMC strategy for Sarepta’s genetic... ..., and technical reports for regulatory submissions or technology transfer. Train...RegulatoryTemporary work- A global pharmaceutical leader is seeking an Executive Director to drive the global value evidence strategy. This role involves overseeing strategic planning for evidence generation,... ...mentoring teams, and ensuring compliance with regulatory standards. The ideal candidate will...Regulatory
$203k - $253k
Teleflex is seeking a Senior Director, Strategic Regulatory Affairs & UDI, based in Morrisville, NC. This role leads global regulatory operations, ensuring compliance and... ...will empower teams, develop organizational strategies, and partner with various functions to drive business...Regulatory$150k - $200k
...NYSE/TSX: BLCO) is a leading global eye health company dedicated... ...Responsible for project strategies, risk assessments, biocompatibility... ...activities, and with key regulatory expectations and milestones... ...matters for country-specific submissions/registrations and...RegulatoryTemporary workRemote workWork visa- ...biopharmaceutical company in North Carolina seeks an experienced Senior Director, Head of Regulatory Affairs. This role involves defining global regulatory strategy and overseeing submissions, with a focus on biologic products. Candidates should have over 15 years of...Regulatory
- ...: Associate Director/Director, Regulatory CMC Location: North Carolina/Remote... ...Regulatory CMC compliance with global (both U.S. and ex‑U.S.) regulations and submission requirements for clinical... ...executing global CMC regulatory strategies, providing guidance on risk mitigation...RegulatoryContract workRemote work
- Grifols seeks a Regulatory Affairs professional in Clayton, NC to implement global registration strategies, ensuring compliance with labeling requirements for product shipments... ...various departments to manage regulatory submissions effectively. Qualified candidates should...Regulatory
- Solesis is seeking a full-time Regulatory Affairs Specialist for Quality Assurance in Winston-Salem, NC. The candidate will plan and implement strategies for obtaining regulatory approval for medical devices, ensuring compliance with US, EU, and international standards...RegulatoryFull time
- ...seeking an experienced leader in Learning & Development to oversee global initiatives in Raleigh, North Carolina. This role demands a... ...candidate will have over 8 years of experience and a firm grasp of regulatory compliance and innovative learning methodologies....Regulatory
- Teleflex is hiring a Staff Scientist to lead biocompatibility evaluations and oversee testing for R&D and design control changes at... ...strong chemistry or biology background, experience in regulatory strategy, and the ability to mentor Biocompatibility Specialists while...Regulatory
- ...meetings, scientific advisory boards, and regulatory meetings). Write, review, edit, and... ...private information, please review Insight Global's Workforce Privacy Policy: Skills and... ...clinical trials, and global regulatory submissions Knowledge of FDA and/or EMA regulations,...Regulatory
$190k - $210k
.... We are currently hiring a CMC Regulatory Strategist to join our team!... ...development programs and regulatory submissions. You will serve as Rho's... ...Rho staff in CMC regulatory strategy and product development by... ...CMC deliverables against Global Integrated Product Development...RegulatoryHourly payCurrently hiring- Xylem is a Fortune 500 global water solutions company dedicated to advancing sustainable... ...to lead the MCS segment’s quality strategy and ensure that our products, services,... ...operations meet or exceed industry standards, regulatory requirements, and customer expectations....Regulatory
- Senior Manager, Regulatory Strategy ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines... ...Take part in preparation of strategic development and submission plans. Be involved in the regulatory affairs...Regulatory
- ...Description The Staff Environmental Scientist will support NPDES permitting,... ...of the Environmental Services Global Practice based upon Burns &... ...: Apply environmental regulatory knowledge and experience to develop effective strategies and solutions to current and future...RegulatoryFull time
- Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals is a privately held, specialty... ...Affairs to lead global regulatory strategy and execution across a diverse and... ...through post‑approval, ensuring timely submissions, approvals, and global compliance. Key...RegulatoryWork at officeWork from home
- ...We are seeking a strategic and influential VP, Global Head of Regulatory Affairs to lead global regulatory strategy and execution across a diverse and complex portfolio... ...through post-approval, ensuring timely submissions, approvals, and global compliance. Key Responsibilities...RegulatoryFull timeLive inWork at officeWork from home
- ...rich history. As a leading global aesthetics business, our award... ...Lead the team within Global Regulatory Affairs that provides... ...Advertising & Promotional Compliance strategy and governance framework,... ...aspects of reviewing regulatory submissions and communications with the...RegulatoryFixed term contract
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