Global CMC Regulatory Manager, Rare Diseases
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A. is seeking a Senior Manager, CMC Regulatory Affairs for Global Rare Diseases in a hybrid Cary, NC role. You will lead CMC documentation, author sections for MAAs and variations, and advise cross-functional teams on regulatory expectations worldwide. The position requires 5+ years in Regulatory CMC, deep knowledge of ICH/US/EU guidelines, and strong collaboration with Core teams and external CMOs. Competitive base pay and comprehensive benefits are offered. #J-18808-Ljbffr Chiesi Farmaceutici S.p.A.
- ...challenge the status quo for the better. Chiesi Global Rare DiseasesChiesi Global Rare Diseases is a Chiesi Group’s business unit... ...forThis is what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience to support...SuggestedHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
- ...Raleigh, NC seeks an Associate Director/Director/Sr. Director, Regulatory CMC to lead global CMC regulatory strategy for clinical development and... ...partnering with CMOs and external experts to support product lifecycle management and #J-18808-Ljbffr TG Therapeutics, Inc.Suggested
$110k - $150k
...Liberty airport.Position SummaryWe have an opportunity for a Manager, Global Trade Compliance to join our team. In this role, you will... ...recommendations related to projects, supply chain changes, regulatory updates, and transactional activities.Other duties as assigned...SuggestedFull timeWork at officeLocal area- Amgen seeks a Medical Science Liaison in Rare Disease to cover VA and Eastern NC, including Raleigh/Durham. You will build and maintain relationships with leading clinicians and researchers, communicating scientific data and medical value to diverse audiences. This role...Suggested
$220k - $270k
...highly motivated individual to serve as Global CDMO Compliance Officer for its FUJIFILM... ...role in helping FUJIFILM Biotechnologies manage new and evolving compliance risks.This... ...SummaryRequisition ID: 2026-37198Category: Regulatory/ComplianceCompany (Portal Searching):...SuggestedContract workLocal areaFlexible hours- ...are looking for a Sr. Director, CMC to join our A-team (hybrid*/... ...early-stage evaluation through regulatory submission and commercial... ...early development through Phase 4.Manage and lead direct reports through... ...distance from one of our global offices.“The Allucent Talent Acquisition...Full timeFor contractorsWork at officeRemote workFlexible hours2 days per week
- ...cardiovascular, and metabolic disease indications with a... ...promoters. With global headquarters in... ...Director, Regulatory Affairs will serve... ...Clinical, Nonclinical, CMC, Quality, Medical, Project Management, and other functions... ...based gene therapy, rare disease, biologics,...Work at officeLocal areaRemote work
- Bioventus is seeking a Regulatory Affairs Manager in the United States to lead global regulatory strategies and submissions for biologics products. You will collaborate with R&D, Engineering, Quality, and Operations to ensure compliance and timely approvals. The role requires...
- ...or DC seeks a Senior Director of International Affairs to lead global government relations and policy strategy. You will partner with... ...evidence-based positions. You will build and mentor a team, shape regulatory priorities across WTO, OECD and other forums, and translate...
- Join to apply for the Regulatory Affairs Manager role at Align Technology . 6 days ago Be among the first 25 applicants. Description The Regulatory... ...accordance with health authority regulations/guidance and global standards. The devices in scope include standalone physical...Work at office
- A leading global construction company is seeking a Director, Legal to serve as the sole in-... ...This role involves overseeing legal affairs, managing external counsel, and providing strategic legal guidance on corporate and regulatory matters. The successful candidate will...Remote work
- A leading global construction brand in North Carolina is seeking a Director, Legal to oversee all legal affairs. The candidate will manage corporate governance, compliance, and litigation matters while providing strategic legal guidance to senior leadership. This role...Remote work
- ...Import Export Coordinator in Raleigh, NC. You will manage daily export documentation, ensure regulatory compliance, and coordinate shipments with carriers and... ...supports continuous process improvements in global trade operations. #J-18808-Ljbffr Sumitomo Electric...
- Grifols seeks a Regulatory Affairs professional in Clayton, NC to implement global registration strategies, ensuring compliance with labeling requirements for product... ..., and collaborating with various departments to manage regulatory submissions effectively. Qualified candidates...
$85.1k - $106.4k
...Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based... ..., urology, women's health, rare diseases, cell & gene therapies and... ...II reporting to the Senior Manager Quality Assurance of Cell Quality... ...ensuring compliance with regulatory requirements, company...Work at officeRemote workFlexible hoursShift work- ...treatments for B-cell diseases. In addition to a research... ...Healthcare Products Regulatory Agency (MHRA) for... ...implementing, and overseeing global regulatory strategy... ...guidance to senior management on regulatory risks, opportunities... ...Clinical Development, CMC, Pharmacovigilance, Ad...Worldwide
- ...collaborate with cross-functional teams to address unmet needs. In this field-based role, you will travel up to 60% for territory management, regional conferences, and investigator-initiated trial support, contributing to the medical strategy and scientific leadership...Remote job
- Amgen is seeking a Medical Science Liaison to serve as a scientific liaison to the medical and scientific community. The role focuses on establishing relationships with experts and clinicians across the US, communicating scientific and medical information, and supporting...
- ...Overview We are seeking a strategic and influential VP, Global Head of Regulatory Affairs to lead global regulatory strategy and execution... ...Direct global submissions and approvals while managing risks Lead interactions and negotiations with FDA, EMA,...Full timeLive inWork at officeWork from home
- ...department, focusing on shipping regulations, import/export, and regulatory initiatives in alignment with Good Clinical Practice. The role... ..., building cross-functional partnerships, and driving process improvements in global logistics operations. #J-18808-Ljbffr IQVIALocal area
$112k - $153k
...lives of people who live with a rare disease. Our edge comes from our... ...distance to Raleigh, NCThe QA Manager, GCP is responsible for:... ...IND/CTA submissions under the global umbrella. Support the collection... ...and FDA, EMA and ROW regulatory requirements. Quality assurance...Temporary workLocal areaFlexible hours$172.5k - $222.5k
...platform companies, building the foundation of a more open, global economy through digital assets, payment applications, and... ...you’ll be responsible for: Circle is looking for a Senior Manager to join the Regulatory Assurance team who will help to create a central global...Flexible hours- ...rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives. The Regulatory Affairs Manager is responsible for developing and executing global regulatory strategies to plan,...
$88k - $108k
...QA WHO WE ARE – Indivior is a global pharmaceutical company... ...recognized and treated chronic disease. Building on its global portfolio... ...conducting site self‑inspections, managing Change Control and CAPA... ...of inspection readiness and regulatory compliance Participate in multi...Shift work$125k - $160k
..., Inc. Job Description: The Senior Manager, Peer-to-Peer Strategy & Engagement is... ...across brand, field leadership, medical, regulatory, and agency teams to ensure compliant,... ...Experience working within specialty and/or rare disease markets; nephrology experience...Full timeWork at office- ...release, and in-process testing strategies for Drug Substance and Polysaccharides, coordinating with Process Development, MSAT, QC, Regulatory, and CMOs. The role requires building and leading high-performing QA teams, driving continuous improvement, supporting #J-18808-...Remote job
- ...Vice President, Human Resources to serve on the executive leadership team in Raleigh, NC. You will shape and execute the companys global people strategy, partnering with the CEO and Board to attract, develop, engage, and retain top talent while driving accountability...
- ...dreams and become part of a global team of over 50,000 planners,... ...innovators, program and construction managers and other professionals... ...workday) climbing stairs. Rarely (less than 10% of the workday... ...New Source Review permitting, regulatory reporting, permit renewals, major...Full timeWork at officeLocal areaWorldwideRelocation packageFlexible hours
- Associate Director, CMC Product Development - Small Molecule About... ...autoimmune and inflammatory diseases. With a portfolio of... ...manufacturing, direct CDMO technical management experience, and the ability... ...to drug product sections of regulatory submissions (IND, IMPD, NDA)...Contract workLocal areaImmediate start2 days per week
- Principal Product Manager for Intelligent Planning - Hybrid, Cary, North Carolina or remote in NCWe’re a leader in data and AI. Through... ...supply chain analytics and performance management to large global manufacturing, industrial, and consumer goods organizations.Capabilities...Full timeLocal areaRemote workWork visa
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