Senior Regulatory Affairs Expert

**About the Role:**We are seeking a highly skilled Regulatory Affairs Expert to join our team. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with all applicable regulations and guidelines.In this position, you will be responsible for the preparation and submission of clinical trial applications (CTAs)...

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 OverviewWe are seeking an experienced Regulatory Affairs Expert Senior to join our team in Warsaw.The successful candidate will be responsible for monitoring PV compliance indicators, coordinating and managing PV audits and inspections, and performing accurate and scientifically sound data entry in our safety database.Key responsibilities will include...

Our Client, a leading pharmaceutical company, is seeking a talented and motivated Senior Regulatory Affairs Specialist to join their CMC team. As a key member of the team, you will be responsible for supporting global CMC regulatory strategies and documentation.The ideal candidate will have first-hand experience in CMC, regulatory affairs, or a related...

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...

Step into a pivotal role as Manager, Regulatory Affairs and contribute to the global development and lifecycle management of groundbreaking pharmaceutical products. As a key member of team, you will lead the development and execution of global CMC regulatory strategies, ensure compliance with regulatory requirements, and represent Global CMC Regulatory...

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,...

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...

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...

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...

We are seeking a skilled Senior Regulatory Expert to join our team at TN Poland. As a key member of our Scientific and Regulatory Affairs department, you will be responsible for ensuring that our products comply with all relevant laws and regulations in assigned markets.Your primary focus will be on assuring ingredients, formulas, labeling, and packaging...

**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...

We are seeking an experienced Senior Quality and Regulatory Affairs Manager to join our team in Warsaw, Poland. This role will be primarily located at Smith+Nephew's Warsaw office, with occasional travel to 3PL locations.As a Senior Quality and Regulatory Affairs Manager, you will lead a team of quality professionals and be responsible for developing,...

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...

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 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...

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...

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...