CMC Regulatory Expert

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...

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...

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...

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...

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...

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...

Qrios Minds AB is a dynamic and entrepreneurial company that values innovation and excellence. We are committed to developing high-quality products that meet the needs of patients worldwide.As a Regulatory Affairs Manager, you will have the opportunity to contribute to the development of our pipeline products and ensure their successful launch.Your key...

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...

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...

Role Summary:As a Regulatory Affairs Manager at Qrios Minds AB, you will play a vital role in shaping the regulatory strategy for our biopharmaceutical products. Your primary responsibility will be to ensure the compliance of our products with regulatory requirements, while also driving business growth through strategic partnerships and collaborations.Key...

Nasdaq, Inc. is seeking a senior regulatory expert to join our team as a Senior Regulatory Expert. The ideal candidate will have extensive experience working in an area relevant to our function, such as regulatory reporting, MIFID II or EMIR regulation, product/market knowledge in one or more asset classes, trading/trading surveillance, compliance,...

Kenvue is a leading consumer healthcare company with a rich heritage and a passion for science. As Senior Regulatory Affairs Manager, you will be responsible for ensuring the success of new product registrations, line extensions, and new indications and claims in alignment with the business plan, while maintaining compliance for all products with local...

Job Description:We are seeking a highly skilled and experienced Regulatory Compliance Expert to join our dynamic and international regulatory compliance advisory team at Nasdaq, Inc. Our team is dedicated to supporting 8 Nasdaq Exchanges and Nasdaq Clearing with compliance advisory services for the reporting obligations in regulations such as MIFID II/R,...

Job OverviewTN Sweden is seeking a seasoned Regulatory Affairs Expert to lead our global submissions and compliance efforts. In this role, you will work closely with cross-functional teams to ensure timely and accurate submission of regulatory documents.Key Responsibilities:Maintaining current knowledge base of existing and emerging regulations, standards,...

At Alfa Laval Corporate AB, we're pushing the boundaries of what's possible. We're a pioneer in developing sustainable solutions for the future. As a Product Regulatory Expert, you will play a crucial role in ensuring our products meet all relevant regulatory standards.Company OverviewAlfa Laval Corporate AB is a global leader in the development and...

About UsKaro Healthcare is a leading organization in the pharmaceutical industry, committed to making smart choices for everyday healthcare. We own and sell over 80 brands in about 90 countries, catering to various needs and preferences of our customers.Role and ResponsibilitiesThe successful candidate will lead a team of experts responsible for managing...

At Aira, we are driving the clean energy revolution. Our mission is to advance the next generation of home energy solutions, creating intelligent, sustainable homes for a meaningful impact. As a Regulatory Compliance Expert, you will play a crucial role in ensuring our organization complies with all applicable laws, regulations, and industry standards.About...

About this opportunityWelcome to the Model Risk and Validation team at TN Sweden. We add value by advising and challenging the business areas and functions to use models within the bank's model risk appetite. As a Regulatory Expert - Model Risk, you'll play a valuable role in advising stakeholders in complying with model-related regulatory...

SEB Group supports its business being conducted in an ethical, sustainable and compliant manner for the benefit of its customers, shareholders and society. We are seeking a Regulatory Expert to join the Group Compliance team, focusing on supporting Group Technology.The Staff & Support Functions Compliance team was established to further enhance the control...

Job SummaryProPharma Group is seeking a Senior Manager, Regulatory Sciences to lead client projects, ensuring efficient project execution and contributing to larger projects.ResponsibilitiesProject manage assigned projects, including approval of time entry and invoicing, budget monitoring, and client liaison.Provide expert guidance and technical expertise,...