Senior Global Regulatory Affairs Specialist

As a key member of our client's global CMC team, the Senior Regulatory Affairs Specialist will play a critical role in supporting regulatory strategies and documentation.About Our ClientOur client is one of the largest pharmaceutical companies in the world, committed to improving human health through innovative medicines and treatments.Key...

GSK is a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines.As a Senior Regulatory Specialist, Product Variations, CD CMC, you will be responsible for managing CMC regulatory activities required during the lifecycle of our...

About ICON plcICON plc is a leading provider of outsourced development services to the pharmaceutical, biotechnology, and medical device industries. Our mission is to advance human health by helping our customers develop innovative treatments that make a difference in people's lives.We are committed to delivering high-quality results, fostering a culture of...

Job Description:Randstad is partnering with one of the largest pharmaceutical companies in the world to find a highly skilled Regulatory Affairs Specialist to join their CMC team. As a key member of the team, you will play a critical role in supporting global CMC regulatory strategies and documentation.About Our Client:Our client is a well-established...

Job DescriptionWe are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team in Warsaw, Poland.The successful candidate will be responsible for the preparation and submission of regulatory documents and applications to ensure compliance with applicable EU regulations and guidelines.This role will involve coordination of...

About the RoleWe are seeking an experienced Principal Regulatory Strategist to join our team, providing expert consulting and advisory services for complex regulatory issues or projects.The ideal candidate will have a strong background in Regulatory Affairs or Strategy, with experience in Marketing Applications (EMA) and a solid understanding of scientific...

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...

About the RoleThe Regulatory Specialist will play a crucial role in supporting operational activities related to the maintenance of marketing authorizations across assigned markets and submission types in European Partnership Markets.This position requires close collaboration with country leads, global regulatory teams/centers, and local 3rd party service...

ResponsibilitiesPrepare, review, and manage IND, NDA, CTA, and CTD dossiers, as well as lifecycle submissions (e.g., PSURs, PADERs).Represent regulatory affairs in multi-disciplinary teams, providing expertise and strategic input.Support FDA and global agency communications, including labeling submissions, safety reporting, and audit...

Senior Quality and Regulatory Affairs Specialist page is loadedSenior Quality and Regulatory Affairs SpecialistApply locations POL - Warsaw time type Full time posted on Posted 30+ Days Ago job requisition id R79316Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.At Smith+Nephew we are looking for: Senior...

Company OverviewGSK is a global biopharma company that unites science, technology and talent to get ahead of disease together. Our mission is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.We are committed to making GSK a place where people can thrive. We want our employees to feel inspired,...

Company OverviewManpowerGroup Sp. z o.o. is a global firm with over 70 years of experience, operating in 82 countries. On the Polish market, we have been present since 2001 and currently have nearly 35 branches throughout the country. Our goal is to provide job seekers with new opportunities and assist them in finding employment matching their qualifications...

Job SummaryThe MDR, ISO 13485 Specialist plays a pivotal role in ensuring the company's software complies with Medical Device Regulation (MDR) and relevant standards. This position involves leading the preparation and submission of regulatory documentation, maintaining the quality management system, and ensuring ongoing compliance.Key Responsibilities:Lead...

Our MissionAt ICON plc, our mission is to advance human health by helping our customers develop innovative treatments that make a difference in people's lives. We're committed to delivering high-quality results, fostering a culture of innovation, and prioritizing the well-being of our employees and patients.We're seeking a highly skilled and experienced...

OtiPharm Alliance is an ambassador for medical product market entry, with a strong focus 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.We are looking for a Regulatory Affairs Manager to oversee the operational...

We are seeking an experienced Regulatory Affairs Specialist to join our Client's CMC team and contribute to the development of global regulatory strategies.This role involves supporting the implementation of CMC regulatory plans for new compounds and marketed products in collaboration with other RA personnel.Health Authority Interactions: Assist in preparing...

Are you a motivated and detail-oriented Regulatory Affairs professional looking to advance your career in the pharmaceutical industry?About Our ClientOur client is a leading pharmaceutical company dedicated to improving human health through innovative medicines and treatments.Key ResponsibilitiesSupport the development of global CMC regulatory strategies and...

About the RoleWe are seeking an experienced Regulatory Affairs Data Entry Specialist to join our team in the EMEA region. The successful candidate will be responsible for managing data entry processes, ensuring high-quality data accuracy, and developing effective relationships with data owners. If you have excellent analytical and problem-solving skills, and...

For our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for a Regulatory Affairs Manager EMEA , who will provide regulatory support to the Portfolio Leader for a portfolio of marketed oncology and internal medicine drug products which are supported by the Established Products team.If you have relevant experience and would like...

About UsAt ICON plc, we believe in the power of innovation and collaboration to drive human health forward. As a world-leading healthcare intelligence and clinical research organization, we're dedicated to creating a brighter future for patients around the world.We foster a culture of inclusivity, creativity, and growth, where talented individuals can thrive...