Regulatory Affairs Expert

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...

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...

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,...

At ManpowerGroup Sp. z o.o., we are a global leader in the employment industry, operating in 82 countries and serving clients across various industries.Job OverviewWe are seeking a Regulatory Affairs Publishing Specialist to join our team, who will be responsible for executing electronic publishing of regulatory submissions for national, regional, and global...

Job SummaryA highly skilled Regulatory CMC professional is sought to drive global regulatory strategies for innovative pharmaceutical products. This individual will lead the preparation of strategic regulatory plans, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development.Key...

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...

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...

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...

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...

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...

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...

Polpharma S.A. is a leading pharmaceutical company that seeks a highly skilled professional to fill the position of CHC Regulatory Affairs Team Head. In this role, you will lead our CHC regulatory affairs team, providing strategic guidance on registration strategies and ensuring compliance with relevant regulations.Key Responsibilities:Team Leadership:...

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...

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...

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 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...

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...

ManpowerGroup Sp. z o.o., a global leader in workforce solutions, is seeking an experienced Regulatory Affairs Submission Expert to join our team.We are recruiting for a mid-level and senior position that requires collaboration with colleagues to ensure compliance with regulatory agency regulations and interpretation.Main Responsibilities:Create and manage...

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...

**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...