Biopharma Regulatory Manager

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...

Company OverviewScandinavian Biopharma is a leading research-based specialty biopharma company dedicated to improving human health worldwide. We are committed to developing innovative solutions for unmet medical needs, with a focus on vaccines and immunoglobulins.Our team has extensive experience in vaccine development, manufacturing, registration, and...

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 an exciting research-based specialty biopharma company determined to give people all over the world a longer and better life. Our goal is to develop innovative solutions for unmet medical needs.As a Regulatory Affairs Manager at Qrios Minds AB, you will play a crucial role in ensuring compliance with regulatory requirements and guidelines.Your...

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...

About the Company CultureWe are a dynamic and stimulating work environment, with a strong focus on collaboration and teamwork. Our team is dedicated, experienced, and friendly, with an exciting journey ahead.We value service-minded professionals who can work proactively and independently. If you are looking for a challenging and rewarding role in Regulatory...

Om jobbet Vi söker nu en QA Manager till vårt team på Scandinavian Biopharma. Som QA Manager kommer du att arbeta nära andra ledande funktioner för att säkra högsta möjliga nivå av kvalitet i alla aspekter av vårt arbete. En viktig uppgift är att fastställa rutiner och standardiserade processer för våra produkter. Inom ramen för rollen skall...

Role Overview: Project Manager – MDR ComplianceTFS HealthScience is a leading global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service (FSP) solutions.The Project Manager – MDR...

Are you a driven and detail-oriented professional with expertise in navigating the complex landscape of regulatory compliance?TN Sweden is expanding its Medical department, and we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key function within the department, this role will support the organization with strategic regulatory...

We are seeking a skilled Business Development Manager to drive business growth and success in the biotech regulatory space. As a key member of our team, you will be responsible for identifying, developing, and closing new business opportunities that align with our company's goals and objectives.About UsAlbion Rye Associates is a leading consultancy that...

About the RoleWe are seeking a highly experienced Senior Global RA Manager to join our dynamic team in Stockholm. As a key contributor to Chiesi's growth strategy, you will lead the Global Regulatory Team and serve as the regulatory representative on global core teams for assigned projects.Key Responsibilities:Develop and implement global/regional regulatory...

As a Regulatory Compliance Manager at TN Sweden, you'll be responsible for ensuring our business operates within the bounds of regulatory requirements. You'll identify, advise, and evaluate compliance risks, and develop strategies to mitigate potential issues.About the RoleThis is an exciting opportunity to join our Conduct, Advisory and Products Compliance...

Kenvue is built on over a century of heritage and rooted in science. We're the house of iconic brands - Neutrogena, Aveeno, Tylenol, Listerine, Johnson's, and BAND-AID Brand Adhesive Bandages.As Senior Manager of Regulatory Affairs (Nordics), you will drive regulatory excellence across new product registrations, line extensions, and new indications and...

Job OverviewThe Global Labeling Operations Lead plays a critical role in coordinating and managing activities related to the approval and maintenance of printed labeling components.Key Responsibilities:Project Management: Manage labeling and packaging artwork projects affecting multiple products to ensure timely delivery.Lifecycle Management: Coordinate...

We are looking for a seasoned Senior Regulatory Affairs Manager to join our team in Stockholm, Sweden. As a key member of our Regulatory Affairs function, you will play a critical role in ensuring the success of our new product registrations, line extensions, and new indications and claims.Your primary responsibility will be to lead the Regulatory Affairs...

Haeger & Carlsson Executive Search & Interim ABWe are partnering with a renowned life sciences company to find a highly skilled Director Regulatory Affairs. As a key member of the leadership team, you will develop and execute global regulatory strategies to support the submission and approval of biologics.The ideal candidate has a proven track record in...

About TN Sweden:Senior Manager, Regulatory Sciences - DevelopmentJob Summary: We are seeking an experienced Senior Manager, Regulatory Sciences to join our team at ProPharma Group. The ideal candidate will have expertise in nonclinical/clinical regulatory writing, advanced knowledge of nonclinical/clinical strategies for development products, and experience...

About the RoleThe System Quality Regulatory Manager will be responsible for ensuring the Quality Management System (QMS) is compliant with relevant regulations and standards. This includes maintaining awareness of regulatory requirements, identifying areas for improvement, and implementing changes to ensure ongoing compliance.This role involves coordinating...

Job Title: Regulatory Affairs ManagerWe are seeking a highly motivated and experienced Regulatory Affairs Manager to join our team at Qrios Minds AB. In this role, you will play a critical part in developing and implementing our regulatory strategy, ensuring the compliance of our biopharmaceutical products with regulatory requirements.Responsibilities:*...

About the RoleSenior Manager, Regulatory SciencesProPharma Group is a global leader in regulatory sciences, providing expert advice and solutions to biotech, med device, and pharmaceutical organizations.Key ResponsibilitiesLead client projects, ensuring efficient project execution and contributing to larger projects.Author global nonclinical/clinical aspects...