Regulatory Affairs Specialist

We are looking for a skilled Regulatory Affairs Specialist to join our team at Randstad. The successful candidate will be responsible for ensuring compliance with regulations and interpretations of regulatory agencies.Job Description:Operational submission managementDelivery of regulatory submissions required to support product development, registration, and...

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...

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...

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,...

Job Overview:Our client, a leading pharmaceutical company, is seeking a Regulatory Affairs Senior/Specialist in Submission Publishing. The successful candidate 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...

Our client is a leading pharmaceutical company seeking an experienced Regulatory Affairs Publishing Specialist to join their team.The successful candidate will be responsible for executing the electronic publishing of moderate to complex regulatory submissions for national, regional, and global regulatory agencies and operating companies in both eCTD and...

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...

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...

At TN Poland, we are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our CMC team. This role will involve supporting global CMC regulatory strategies and documentation.This is an exciting opportunity for someone who wants to continue their career path in CMC or Regulatory Affairs. If you have experience in the pharmaceutical...

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...

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...

About the RoleWe are seeking a Senior Regulatory Specialist, CTA/IND to join our Polish Hub.Key Responsibilities:Develop and implement regulatory strategies for CTA/IND submissions, ensuring compliance with GSK policy and procedures.Collaborate with cross-functional teams to achieve project goals and deliver high-quality results.Manage and maintain accurate...

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 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...

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...

Polpharma S.A. is seeking a dedicated and experienced professional to join our team as a Compliance and Regulatory Affairs Specialist. In this role, you will be responsible for ensuring compliance with relevant regulations and guidelines related to the scope of conducted tasks.Responsibilities:Regulatory Compliance: Verify and support the implementation of...

We are seeking a highly skilled Regulatory Affairs Publishing Specialist to join our team in Warsaw, Poland.The ideal candidate will have experience in navigating complex regulatory submissions and publishing requirements, as well as excellent communication skills.Job Description:Executing the electronic publishing of moderate to complex regulatory...

We are seeking a highly skilled Regulatory Affairs Submissions Specialist to support our client specialized in pharma industry.About the ClientThe client is a global leader in the pharma industry, with a presence in over 70 countries and a portfolio of products that includes both prescription and over-the-counter medications.Job SummaryThe Regulatory Affairs...

**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...