CMC Regulatory Specialist

Job Description:The successful candidate will provide comprehensive CMC support for internal projects, from GLP toxicology through IND/CTA clinical programs to post-approval NDA/BLA.Main Responsibilities:Ensure timely supply of Drug Substance/Drug Product for non-clinical and clinical studies.Collaborate with internal and external teams in analytical/quality...

RequirementsProven experience in cross-functional management, with the ability to lead diverse, complex projects and timelines successfully.In-depth knowledge of US and EU CMC regulatory requirements for biologics, tailored to different development phases.Experience with technical transfers and managing complex development and manufacturing...

At Qrios Minds AB, we are developing the first vaccine against ETEC, a bacteria causing diarrhea in travelers and endemic populations. We are seeking a highly skilled Regulatory Affairs Manager to join our team.This role offers the opportunity to apply your regulatory expertise within multiple areas during development, focusing on regulatory CMC. You will...

Improving Patient Outcomes with QualityWe are a global company with a passion for improving patient outcomes and transforming the lives of people with rare and debilitating diseases. At Sobi Group, we believe in the power of quality to drive innovation and patient care.About the JobWe are seeking a highly experienced QA Specialist Lead with a strong...

Main ResponsibilitiesDevelop and implement regulatory strategies for CMC-related submissions (IND, CTA, RtQ etc.) for FDA, EMA, and national authorities in third world countries.Collaborate with subject matter experts (SMEs) to develop regulatory documents related to manufacturing (e.g. IMPD, Module 3, Briefing Document).Coordinate and compile regulatory...

About the PositionThe Regulatory Affairs Manager will be responsible for coordinating the regulatory strategy for the development and implementation of changes in the manufacturing process, including changes in the manufacturer (drug substance and drug product).The ideal candidate will have excellent communication skills in speech and writing, with...

Senior Global RA Manager Job DetailsAs a key member of our R&D team, you will be responsible for leading the Global Regulatory Team and serving as the regulatory representative on global core teams for assigned projects.Key Responsibilities:Develop and implement global/regional regulatory strategies for new and existing products, ensuring compliance with...

Job DescriptionAs a key member of our R&D team, you will play a vital role in establishing Chiesi Global Regulatory Affairs in Sweden. Your expertise as a Senior Global RA Manager will be instrumental in leading the Global Regulatory Team and serving as the regulatory representative on global core teams for assigned projects.Key Responsibilities:Leverage...

Company Overview:Qrios Minds AB is a research-based specialty biopharma company committed to delivering innovative solutions that improve people's lives worldwide. Our mission is to develop groundbreaking treatments that address unmet medical needs.Job Summary:We are seeking a talented Regulatory Affairs Manager to join our team. In this exciting role, you...

We are on the hunt for a seasoned professional to fill the role of Regulatory Affairs Specialist at Albion Rye Associates. This position requires an individual who is passionate about regulatory compliance and has a proven track record in ensuring seamless operations within the biotech and pharmaceutical industries.Main responsibilities include: Developing...

About This OpportunityAs a Regulatory Assurance Specialist, you will be responsible for ensuring our regulated products meet the required standards. You will work closely with our Compliance Team to identify areas for improvement and implement measures to mitigate risks.Develop and maintain a deep understanding of regulatory requirements for the Central...

We are looking for a skilled Regulatory Implementation Specialist to support the management of complex regulatory projects within the Transaction Banking unit.About the RoleThe successful candidate will be responsible for supporting the planning, scoping, structuring, and driving of multiple projects simultaneously, while ensuring timely delivery of complex...

About the Role:The successful candidate will work as a Senior Regulatory Specialist alongside other experienced team members who have expertise working with Nasdaq Clearing and our trading venues in the Nordics and Baltics to comply with their regulatory reporting obligations under MIFID II/R, EMIR, and SFTR.Key Responsibilities:Monitoring of regulation...

Career Opportunities at SobiWe are seeking a highly skilled QA Analytical Specialist Lead to join our team and contribute to the development of new treatments.The ideal candidate will have a strong understanding of regulatory guidelines and quality control procedures.

Job OverviewWe are seeking a skilled Regulatory Approvals and Safety Specialist to join our team at Ericsson GmbH. This role will focus on ensuring the safety and regulatory compliance of our radio technologies, including GSM (2G), WCDMA (3G), LTE (4G), NR (5G) and future coming 6G.

About this roleWe are seeking a highly skilled Regulatory Compliance Specialist to join our team in the Business Unit High-Speed Separators. In this role, you will be responsible for ensuring that our products meet all relevant regulatory and safety standards.You will work closely with cross-functional teams to assess, document, and implement compliance...

We are seeking a highly skilled and motivated individual to join our dynamic regulatory compliance advisory team as a Regulatory Compliance Specialist.Job DescriptionThe successful candidate will be responsible for providing expert advice and support on MIFID II/R compliance and governance to our clients. This will involve monitoring regulatory changes,...

Job SummaryWe are seeking a highly skilled and motivated Regulatory Compliance Specialist to join our team in Stockholm. The successful candidate will be responsible for ensuring continued compliance with EASA regulations for the devices stationed at Nordic training centers.This role operates at a supervisory level within the technical team, requiring the...

Transforming Lives with QualitySobi Group is dedicated to delivering innovative therapies that change lives. We are seeking a seasoned professional to lead our quality assurance efforts in analytical activities and stability studies.About the RoleWe are looking for a talented individual with strong communication skills, who can collaborate effectively across...

Chiesi Farmaceutici S.p.A. is a multinational pharmaceutical company committed to improving people's quality of life by acting responsibly towards society and the environment.We are seeking an International Regulatory Compliance Specialist to join our team in Stockholm, Sweden.This role involves ensuring compliance with regulatory standards and guidelines,...