CMC Regulatory Specialist

As a highly skilled Regulatory Affairs Manager, you will play a pivotal role in ensuring the seamless development and manufacturing of our groundbreaking ETEC vaccine. Reporting directly to the VP of Regulatory Affairs, you will be responsible for coordinating regulatory strategies across various areas, including CMC (Chemistry, Manufacturing, and Controls)....

Position OverviewWe are looking for an experienced Lead QA Specialist for GMP Compliance to join our team. As a key contributor, you will be responsible for ensuring compliance with GMP guidelines and regulatory requirements.Key Responsibilities:Develop and implement quality systems for analytical activities, including stability studies.Collaborate with...

Our company, Immense Group, is seeking an experienced Regulatory Affairs Specialist to join our Legal and Compliance department. The ideal candidate will have a strong track record of ensuring compliance with regulatory requirements in the online gaming and betting industry.The successful candidate will be responsible for providing a full range of support to...

Role DescriptionThe Regulatory Compliance Specialist Lead is responsible for ensuring the accurate and compliant labeling of products across various regions.This role involves developing regulatory content for printed labeling components, managing EU SmPC master documents in the Veeva Regulatory Information Management (Veeva RIM) system, and collaborating...

Job OpportunityJoin Zaver's team as a Fintech Regulatory Specialist and play a key role in shaping our regulatory strategy.Our mission is to create a seamless payment experience for all dimensions, making large purchases as easy as buying shoes.Key Responsibilities:Stay up-to-date with regulatory changes and develop strategies to maintain...

TN Sweden is a leading company in the field of pharmacovigilance, and we are seeking a talented Senior EU Regulatory Specialist to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements.Your responsibilities will include:Developing and implementing regulatory...

Samsung Electronics Nordic is seeking a highly skilled Regulatory Affairs Specialist to join our team in Stockholm. As a consultant, you will have the opportunity to work with a variety of clients and projects, gaining valuable experience and expertise in customs and trade.Key ResponsibilitiesAs a Regulatory Affairs Specialist, you will be responsible for...

Senior Regulatory Affairs SpecialistOur team is dedicated to transforming the lives of people with rare and debilitating diseases. We provide reliable access to innovative medicines in the areas of haematology, immunology, and specialty care.As the Senior Regulatory Affairs Specialist, you will be responsible for ensuring the quality and compliance of...

Focused on driving business success through effective risk management, regulatory compliance, and governance.In this role, you will be responsible for developing and implementing strategies to mitigate risks, ensuring adherence to laws and regulations, and fostering a culture of compliance within the organization.Responsibilities:Develop and execute...

We are seeking a Senior Regulatory Affairs Specialist in Medical Technology to develop and implement regulatory strategies, providing guidance on regulatory matters throughout the product lifecycle of medical devices.About the Role:This role requires collaboration with license partners as the Regulatory Affairs Expert, ensuring compliance with healthcare...

As a Regulatory Affairs Specialist at ALTEN, you will be working closely with clients in the pharmaceutical industry to ensure compliance with relevant regulations and guidelines. This involves reviewing and developing validation plans, protocols, and reports, as well as investigating deviations and implementing corrective actions.You should possess strong...

Job Description:We are proud to partner with Planet Pharma, a pioneering biotechnology company at the forefront of advancing monoclonal antibodies, particularly in transplantation and autoimmunity research. Their innovative immune-modulating strategies involve conducting extensive global clinical trials and exploring new preclinical therapies.The company is...

ResponsibilitiesThe Regulatory Affairs Specialist for Pharmaceuticals will be responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders. This includes overseeing product release, supplier qualifications, and quality technical agreements.You will implement and maintain quality risk assessments and KPIs, manage...

About the RoleWe are seeking a highly skilled Senior Quality Assurance Manager to lead our quality assurance efforts in analytical activities. As a key member of our team, you will be responsible for ensuring compliance with GMP guidelines and regulatory requirements.Key Responsibilities:Act as GMP specialist for analytical activities, including stability...

Job RequirementsTN Sweden is seeking a highly motivated and detail-oriented Regulatory Affairs Manager to join our expanding Regulatory, QA & PV team within the Medical department.This role will provide an exciting opportunity for you to utilize your knowledge of regulatory and marketing compliance in a dynamic environment. As a key member of our team, you...

Bondi Chefrekrytering AB is a leading company in the Medical Technology sector, and we are looking for a highly skilled Med Tech Regulatory Compliance Specialist to join our team.Job Description:The successful candidate will be responsible for developing and implementing regulatory strategies, providing guidance on regulatory matters throughout the product...

We are seeking a highly skilled Senior Regulatory Consultant to join our team at TN Sweden. As a key member of our Regulatory Affairs Division, you will play a crucial role in providing expert regulatory advice and support to our clients.Key Responsibilities:Working with Regulatory Affairs on local and regional projects, focusing on the Nordic countries...

The regulatory affairs specialist will play a critical role in supporting the management of QMS processes in our virtual organisation. This includes managing, maintaining, and supporting the eQMS.Main Tasks & Responsibilities:Enter quality-related issues into the eQMS and track that actions and tasks are completed on time.Escalate any overdue records to the...

Job OverviewThe Regulatory Reporting Manager plays a critical role within the Regulatory Operations team, overseeing the submission of regulatory reports and trade surveillance data. This position is responsible for ensuring timely, accurate, and complete reports in accordance with specific regulations.

TN Sweden is a pioneering medical device business dedicated to harnessing cutting-edge biotechnological manufacturing methods to drive innovation in biomaterials.As a Medical Affairs Manager, you will contribute to this mission by providing medical and scientific support for the company's products, collaborating with management, regulatory affairs, and...