Medical Devices Regulatory Affairs Expert

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...

Role OverviewWe are seeking a highly skilled Regulatory Affairs Expert to join our team at Randstad Polska Sp. z o.o.The successful candidate will be responsible for ensuring compliance with regulations and interpretations of regulatory agencies in the pharmaceutical industry.This is an exciting opportunity for a motivated individual to contribute to the...

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 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 an experienced Medical Devices Auditor Expert to join our EIMEA Medical Devices Auditing Team. As a key member of our team, you will be responsible for ensuring patient safety while supporting timely market access for our clients' medical device products globally.Key ResponsibilitiesProvide technical expertise in High Risk...

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...

Qualifications & Skills:This role requires a strong background in Life sciences/Pharmaceutical-related science, preferably with a degree in Chemistry, Pharmacy, Biology, or Biochemistry.A minimum of 5 years' leadership experience in Regulatory Affairs, understanding EU-non EU, CIS environment for medicines, and an advantage for medical devices, cosmetics,...

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...

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 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...

At Polpharma S.A., we are seeking a seasoned professional to fill the role of Head of Regulatory Affairs and Compliance. As a key member of our team, you will be responsible for leading our CHC regulatory affairs team, providing guidance on registration strategies, and ensuring compliance with relevant regulations.Responsibilities:Team Leadership: Foster a...

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...

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...

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...

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...

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...

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...