Senior Director, Regulatory Affairs (CMC) - Gene Therapy
Kriya Therapeutics, Inc.
Kriya Therapeutics, Inc. is seeking an Associate Director for Regulatory Affairs (CMC) in Research Triangle Park, NC. The role involves providing expert regulatory guidance, interacting with health authorities, and managing compliance for drug development. The ideal candidate has an advanced degree and at least 8 years in regulatory drug development, especially focused on CMC and gene therapies. The position offers a flexible work environment and comprehensive benefits. #J-18808-Ljbffr Kriya Therapeutics, Inc.
- Sr. Manager-Director, Regulatory Affairs (Respiratory) Full-time A Few Words About... ...Clinical Research, Rehabilitation Therapy and Nursing. REPORTING... ...development, including CMC and possibly, Clinical strategy... ...5% - Provide updates to senior & executive management 5% -...SeniorFull time
$125k - $135k
Fortrea is looking for a Cell & Gene Therapy Clinical Project Manager in North Carolina. This highly responsible role involves managing project strategies, ensuring quality deliverables, and collaborating with various stakeholders in the clinical trial lifecycle. With...Senior- FTINC Fortrea Inc. is seeking a Cell & Gene Therapy Sr. Clinical Project Manager or Project Manager II to join our team. This role involves... ..., risk, and stakeholder expectations while ensuring regulatory data quality. Responsibilities include operational delivery,...Senior
- Associate Director, Regulatory Affairs (CMC) Department: Regulatory Employment Type: Full Time Location: Research Triangle Park, NC Role Overview... ...‑specific guidelines, especially as they relate to gene therapies. Key Responsibilities Provide expert CMC regulatory guidance...SuggestedFull timeTemporary workWork at officeHome officeFlexible hours
- ...FSO team is seeking an Cell & Gene Therapy Sr. Clinical Project Manager... ...is overseen by a Project Director and involves managing domestic... ...and/or global projects. The Senior Project Manager develops and... ...the accuracy and quality of regulatory data. Line management and...SeniorContract workWork at officeFlexible hours
- ...Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat... ...execute our regulatory vision. The Senior Director, Head of Regulatory Affairs, will serve as the company’s regulatory... ...Partner with Clinical Development, CMC, Pharmacovigilance, Ad & Promo, and...SeniorWorldwide
- Kriya Therapeutics, Inc. is seeking a Senior Director, Pharmacovigilance to lead the pharmacovigilance... ...the safety of investigational and marketed gene therapy products. This role involves overseeing safety programs, regulatory compliance, and cross-functional collaboration...Senior
- ...is building for the next phase of growth and is seeking a Senior Manager, Regulatory Affairs who can operate successfully in a fast-moving, small-... ...study teams and provide practical guidance on clinical, CMC, device, nonclinical, labeling, and lifecycle considerations...Senior3 days per week
- ...Senior Manager, Regulatory Strategy ICON plc is a world-leading healthcare intelligence and clinical... .... As a Senior Manager, Regulatory Affairs at ICON, you will design and analyse... ...of innovative treatments and therapies. What You Will Do: Your focus...SeniorRemote jobFlexible hours
$108.5k - $201.5k
U473 (FCRS = US473) Novartis Gene Therapies in North Carolina seeks a Sr. Project Manager to lead capital projects within regulated manufacturing environments. The role involves managing project scope, budget, and stakeholder relationships, ensuring timely delivery and...Senior- Title: Associate Director/Director, Regulatory CMC Location: North Carolina/Remote If you are interested in the below position, please send your... ...required; experience with monoclonal antibodies or cell‑based therapies preferred. Demonstrated expertise in product...Contract workRemote work
- U473 (FCRS = US473) Novartis Gene Therapies in Durham, NC is seeking a Senior Specialist Maintenance Planner Scheduler to ensure critical equipment operates efficiently. This onsite role demands extensive experience in pharmaceutical manufacturing and technical knowledge...Senior
$153k - $211k
Swedish Orphan Biovitrum AB (publ) is seeking a CMC & Manufacturing, Science and Technology Drug Substance Lead in Raleigh, NC. This... ...manufacturing at external sites, and ensuring compliance with regulatory standards. Ideal candidates will have a strong background in...Senior- Senior Director, Pharmacovigilance Department: Clinical Employment Type... ...is to develop life-changing gene therapies for diseases affecting millions... ...adverse events, and ensures regulatory compliance. The Senior... ...including clinical, regulatory, CMC and quality assurance to...SeniorFull timeTemporary workWork at officeHome officeFlexible hours
- 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...Senior
- 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...Remote job
- ...looking for? We are looking for a Senior Compliance Manager who will be responsible... .../renewals, and works directly with regulatory bodies on regulatory exams and inquiries... ...responsibility Coordinate with Compliance Directors and CCO to maintain the governance...SeniorTemporary workWork experience placementWork at officeLocal areaFlexible hours
- ...digital libraries in a collaborative manner. Position Summary The Senior Compliance Manager provides advanced leadership in support of... ...raised by other Program Managers. Reporting to the Research Director for Physical Sciences, the Senior Program Manager is primarily...SeniorFull timeContract workLive inWork at officeLocal area
- A healthcare services provider in Garner, NC is seeking a qualified Behavior Analyst responsible for developing and overseeing ABA treatment plans. This role includes training a team of Behavior Technicians and ensuring quality patient care. Ideal candidates should have...SeniorRelocation package
$130k - $190k
Veristat, LLC is seeking a Senior Business Development Director to drive growth across Regulatory Science and Medical Writing services in the pharmaceutical and biotechnology... ..., with a proven track record in regulatory affairs and medical writing services. This role...SeniorRemote job- A leading 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...Senior
- ...multidisciplinary team. The role involves diagnosing and treating mental and emotional disorders through individual, group, and family therapy while completing psychosocial assessments and treatment plans. The ideal candidate holds a Master’s degree in Social Work,...Senior
- Duke PF in Raleigh, North Carolina is seeking a compassionate Physical Therapist to provide comprehensive care to patients. The role includes developing plans of care, evaluating patients, and facilitating education for both patients and families. You will work as part ...Senior
$288.2k - $360.2k
...women's health, rare diseases, cell & gene therapies and CNS. With several marketed... ...Pharmacovigilance and Risk Management (PVRM) Senior Medical Director will be responsible for the medical... ..., local approved labels, RMP/REMS, Regulatory Authorities safety inquiries, IRB/...SeniorWork at officeLocal areaRemote workWorldwideFlexible hours- Threadneedle group is seeking a Senior Manager of Financial Reporting to oversee the preparation and compliance of financial reporting... ...and the ability to influence strategic outcomes while managing regulatory obligations. The ideal candidate should have at least 7 years...Senior
$153k - $211k
Sobi - Swedish Orphan Biovitrum AB (publ) is seeking a Senior Subject-Matter Expert in Raleigh, NC. The role involves overseeing synthesis processes for small-molecule drugs, collaborating with external manufacturers, and leading cross-functional teams. Candidates should...Senior- HITT Contracting in Raleigh, North Carolina, seeks a qualified Safety Manager to lead safety initiatives across business units. The role requires a deep understanding of safety protocols, performing inspections, and supporting team development. Ideal candidates hold a Bachelor...Senior
- ...compliance activities related to servicing and asset management. This senior role requires extensive experience in compliance management... ...management systems, conduct testing, and ensure adherence to regulatory requirements, including TILA, RESPA, and more. #J-18808-Ljbffr...Senior
- Principal Financial Group in Raleigh, NC is seeking an Assistant Director - Compliance to lead and develop the compliance team supporting Principal Funds Distributor, Inc. and Principal Securities, Inc. This role involves evaluating workflows and ensuring compliance processes...SeniorFlexible hours
- ...have a relevant degree and significant experience in quality assurance, preferably in plasma or pharmaceuticals. Strong communication and organizational skills are essential. This is a full-time position offering a mid-senior level opportunity. #J-18808-Ljbffr GrifolsSeniorFull time
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