Global CMC Regulatory Scientist: Shape Submissions
UCB Inc.
UCB Inc. is seeking a Regulatory CMC Scientist to join our Global Regulatory team based in Atlanta. The role involves defining strategies for CMC submissions and ensuring timely approvals with a focus on collaboration across various teams. A Bachelor's degree is required, with significant experience preferred in Regulatory Affairs CMC within the pharmaceutical industry. We offer a hybrid work model, fostering a culture of collaboration and innovation. Join us to make your mark for patients while advancing your career in a supportive environment. #J-18808-Ljbffr UCB Inc.
- UCB is looking for a Regulatory CMC Scientist to join our Global Regulatory team. This role, based in Atlanta, GA, involves defining submission strategies and leading CMC regulatory submissions. The candidate should have a robust background in the pharmaceutical industry...Regulatory
- Make your mark for patients We are looking for a Regulatory CMC Scientist to join our Global Regulatory team, based in our Raleigh, NC or Atlanta, GA... ...planning and preparation (writing and review) of CMC submission documentation for regulatory submissions (new marketing...RegulatoryLocal area
- ...contract research organization is seeking a CMC Regulatory Affairs Manager to oversee the preparation, review, and submission of regulatory filings related to CMC. This role... ...degree and experience interacting with global health authorities. Join us to drive regulatory...RegulatoryContract work
$150.03k - $224.25k
Job Summary Provide CMC regulatory strategy input and expertise in the area of investigational... .../maintained in compliance with global regulatory requirements and guidances.... ...technical requirements for CMC and GMP related submissions and inquiries. Represents CMC RA in project...RegulatoryContract workTemporary workWork at officeLocal areaFlexible hours- Cardinal Health is seeking a Scientist I - CMC to support regulatory documentation and cross-functional collaboration. The candidate will ensure compliance with FDA and global standards, requiring a Bachelor's degree in a related field and experience with regulatory writing...RegulatoryRemote jobWork at office
- ...Pharmaceutical Inc. in Atlanta is seeking an experienced CMC Regulatory Strategist to provide regulatory strategy input... ...CMC-related scenarios, ensuring compliance with global requirements, and preparing essential submissions to regulatory authorities. The ideal candidate...Regulatory
- Amgen is seeking a Global Pharmacovigilance Senior Scientist to lead safety assessments and collaborate with Therapeutic Safety Teams on regulatory safety decisions. You will author safety documents, oversee trial safety, and manage signal detection activities to support...RegulatoryRemote job
$140.8k - $190.49k
## Global Pharmacovigilance (PV) Senior ScientistApplyremote type: Remotelocations: United... ....**Global Pharmacovigilance (PV) Senior Scientist**## **What you will do**Let’s do this.... ...Reports and other safety documents and regulatory responses in collaboration with the GSO*...RegulatoryRemote workFlexible hours- ...excellent communication skills, and a strong understanding of project management principles. This position offers a dynamic work environment where innovation is celebrated and you'll work closely with executives from various global organizations. #J-18808-Ljbffr Prorize
- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for Chemistry... ...rare disease therapeutics. The role requires managing global regulatory submissions and team collaborations, necessitating extensive experience...RegulatoryRemote job
- CMC Regulatory Affairs Manager at Katalyst CRO Responsibilities Lead preparation, review, and submission of CMC sections of regulatory filings (INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities. Provide regulatory guidance and support to cross...Regulatory
$1,120 per unit
...Theory and concepts of community/public/global health utilizing levels of prevention are... ...role as a partner with the community to shape conditions supportive of health is emphasized... .... Complies with all applicable regulatory rules and standards. Reports to the dean...RegulatoryPart timeFlexible hoursWeekend work1 day per week$94k - $135k
Senior Scientist, Molecular Assay Development in R&D Passionate about... ...reports to support FDA submissions. You are expected to collaborate... ..., quality control, regulatory affairs, and the clinical lab... ...understanding of FDA, EUA, and other global regulatory requirements...Regulatory- ...EY is seeking a Senior Manager for its Life Sciences Regulatory Submissions practice. This role is crucial in driving growth and establishing... ...and the ability to navigate complex market dynamics. Join EY to shape the future of the life sciences sector. #J-18808-Ljbffr...Regulatory
$150k - $195k
...Director, Technical Operations CMC Strategy is responsible for... ...collaborate closely with Quality, Regulatory Affairs, Clinical, and Supply... ...CMC sections of regulatory submissions, responses, and health... ...compliance with applicable cGMP and global regulatory requirements....RegulatoryContract workTemporary workRemote work$75k - $95k
...Overview We are seeking a Mid-Level Scientist/Ecology to join our team in... ...with federal funding) and regulatory consultation experience with... ...we work. These principles shape our culture, guide our decisions... ...and clients, and our global team of consultants, designers...RegulatoryTemporary workFlexible hours$60k - $85k
Environmental Scientist - Remediation - 4 years minimum experience Full... ...dreams and become part of a global team of over 50,000 planners,... ...communications with clients, regulatory officials, and fellow... ...transforming our industry and shaping the future. With cutting‑edge...RegulatoryFull timeFor subcontractorWork at officeLocal areaWorldwideFlexible hours$189k - $246k
Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute... ...functional teams and leading regulatory submissions for pivotal trial designs and marketing... ...should have significant experience with global health authorities, ideally with a...RegulatoryRemote job$150k - $200k
...Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to... ...cycle management activities, and with key regulatory expectations and milestones Ensures that... ...nonclinical safety matters for country-specific submissions/registrations and maintenance of...RegulatoryTemporary workRemote workWork visa- Parexel is seeking a Regulatory Affairs Consultant/Senior Consultant to guide complex global clinical development programs through the regulatory landscape with strategy... ...focuses on health authority interactions, submission planning, compliance oversight, and strategic...Regulatory
- ...in Atlanta, GA is seeking a Director of Regulatory and Quality to build a Quality Management... ...responsibility, including leading FDA submissions for a pipeline of cardiac monitoring and... ...environment. This is a unique opportunity to shape compliance and product decisions without...Regulatory
- Overview Ready to take your career global? Make your mark at one of the biggest names in... ...our ever-evolving Payroll team and help shape the future of global commerce. What You’ll... .... Resolve complex tax inquiries and turn regulatory changes into clear actions that keep processes...RegulatoryLocal areaWorldwide
- ...trusted in the highest-stakes legal, risk, and regulatory matters around the world. When you join... ...institutions to answer complex questions that shape critical financial, economic, and strategic business decisions. Our globally integrated teams are united by ambition, energy...RegulatoryWork experience placement
- ...Security or a related field and experience in security program operations, with a focus on both technical and compliance aspects. The position offers a collaborative work environment with emphasis on automated processes and regulatory compliance. #J-18808-Ljbffr Ice ServicesRegulatory
$76k - $125.3k
...: Anywhere in Country At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take... ...preparation and review of complex tax/accounting regulatory and tax compliance with limited supervision....RegulatorySummer holidayFlexible hours- ...international health agencies to guide national and global elimination priorities. The Task Force... ...stakeholders. Collaborates with scientists on the development and implementation of... ...strategies. Lead the development and submission of peer‑reviewed manuscripts,...Part timeRemote workWork from homeFlexible hours
$80k - $110k
JLL empowers you to shape a brighter way . Our people at JLL are shaping the future of... ...forward. Position Overview We are seeking a Global Workplace Experience Performance Analyst... ...and safety, food safety, and operational regulatory requirements. Develop and maintain...RegulatoryDaily paid- ...care for animals,' is what unites us in all our roles. We are a global animal health company dedicated to serving veterinarians,... ...Interact with interdepartmental customers such as Manufacturing, Regulatory, and Quality Assurance Perform laboratory testing associated with...RegulatoryFlexible hoursWeekend work
- ...We are looking to fill a Scientist II or III - Metrology Specialist position working as... ...during audits Ensure compliance with all regulatory requirements (cGMP) and internal... ...About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical...RegulatoryFull time
- ...artifact analysis and assist in curation efforts Coordinate regulatory compliance efforts with federal, state, and private entities... ...future-ready culture where agility, innovation, and collaboration shape how we work every day. When you join VHB, you'll find:...RegulatoryWork at officeRelocationRelocation packageFlexible hours
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