Regulatory Affairs Specialist

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...

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...

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...

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,...

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...

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...

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...

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...

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...

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...

**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)...

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...

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...

Company OverviewTN Poland is a dynamic organization that prides itself on embracing diversity and inclusion, delivering better outcomes by reflecting the perspectives of our diverse customer base.Job DescriptionThe Regulatory Affairs Manager CEE & CIS role at TN Poland involves leading regulatory strategy development and execution for CIS and non-EU CEE...

Social network you want to login/join with:At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The...

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...