Regulatory Affairs Coordinator

Job SummaryWe are seeking an experienced Regulatory Affairs Coordinator to join our team.In this role, you will be responsible for ensuring that regulatory submissions are prepared and submitted in accordance with regulatory requirements.You will work closely with cross-functional teams to ensure that regulatory documents are accurate and complete.The ideal...

Regulatory Affairs SpecialistThis role involves handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). It requires ensuring Regulatory Affairs compliance according to local legislation and Standard Operating Procedures (SOPs).Main Responsibilities:Prepare and submit Regulatory...

Are you passionate about regulatory affairs and project management in the pharmaceutical industry?About UsTN Poland is a leading provider of pharmaceutical services, and we are seeking a dynamic Regulatory Affairs Associate to join our Labelling & Artwork team.About the Role: As a Regulatory Affairs Associate focusing on Secondary Packaging & Artwork, you...

Indero, a contract research organization specialized in dermatology and rheumatology, is seeking a highly skilled Regulatory Affairs Specialist. As a key member of our team, you will be responsible for ensuring the quality and compliance of regulatory documents and submissions. This role requires strong knowledge of EU regional regulatory guidelines and...

At TN Poland, we are seeking a seasoned Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will play a critical role in ensuring compliance with complex regulatory issues and projects.Responsibilities:Provide consulting and advisory services for regulatory matters.Author and maintain documentation to sustain...

TN Poland is a global leader in clinical research services, and we are looking for a highly qualified Regulatory Affairs Manager to join our team. As a Senior Quality Assurance Auditor, you will be responsible for conducting audits that impact business operations, processes, and systems.The Regulatory Affairs Manager will have extensive experience in quality...

Parexel, a leading Clinical Research Organization (CRO), is seeking an experienced Principal Regulatory Affairs Consultant to join their team in Warsaw. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.This is a...

Regulatory Affairs Specialist Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Warsaw, Poland.Key Responsibilities:Prepare and submit regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards.Coordinate regulatory timelines and deadlines for all assigned projects...

**Job Title:** Manager, Regulatory AffairsContribute to Global Development and Lifecycle ManagementYou will lead the development and execution of global CMC regulatory strategies, ensuring compliance with regulatory requirements and representing Global CMC Regulatory Affairs in cross-functional and external collaborations.About This Opportunity:This is an...

Regulatory Affairs Manager/Senior Manager in Global LabelingWe are seeking a highly skilled Regulatory Affairs Manager/Senior Manager to join our team at {company}. This individual will be responsible for ensuring the quality of primary and derived labeling documents, providing support for these documents, and contributing to the global labeling strategy.Key...

About the PositionSQUARE ONE RESOURCES sp. z o.o. is looking for a highly skilled Regulatory Affairs Specialist to join their team. The successful candidate will be responsible for drafting and reviewing contractual documents related to digital solutions, including Subscription Agreements, Services Agreements, License Agreements, Data Processing Agreements,...

For our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for a Regulatory Affairs Senior / Specialist in Submission Publishing who will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional and global regulatory agencies and operating companies in both eCTD and non-eCTD...

Job Description:GSK is a global biopharma company that unites science, technology, and talent to get ahead of disease together. Our ambition is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.We are looking for a skilled Regulatory Affairs Specialist to join our team in Poland. As a key member...

Social network you want to login/join with:Specialist, Regulatory Affairs (Poland), WarsawClient:InderoLocation:Warsaw, PolandJob Category:OtherEU work permit required:YesJob Reference:0b22dd25b017Job Views:3Posted:21.03.2025Expiry Date:05.05.2025Job Description:Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In...

Job SummaryA highly skilled Regulatory CMC Manager is sought to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. This individual will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development.Key...

as Manager, Regulatory Affairs Established Products, you will be responsible for the regulatory support of a portfolio of established oncology and internal medicine products. Your objective will be to ensure compliance with regulatory requirements and to implement the global regulatory strategy for post-approval products.Regulatory Affairs Established...

Job DescriptionGSK is a global biopharma company with a mission to unite science, technology, and talent to get ahead of disease together. As a Senior Regulatory Specialist, you will play a critical role in ensuring the lifecycle of GSK products complies with regulatory requirements.Key Responsibilities:Manage multiple CMC variations and source transfers of...

We are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. In this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. This...

Job DescriptionOtiPharm Alliance is a leading ambassador for medical product market entry, focusing on Central and Eastern Europe and the Middle East. Our mission is to enhance patient access to medicines, medical devices, and dietary supplements by addressing shortages and unmet medical needs.Key ResponsibilitiesRegulatory Submissions: Coordinate the...

About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Innovaderm. As a key member of our regulatory department, you will be responsible for ensuring compliance with applicable EU regional regulations and guidelines.The ideal candidate will have a strong background in clinical research, excellent knowledge of GCP and...