Pharmaceutical Regulatory Expert

Regulatory Affairs RoleThe Regulatory Specialist will be responsible for supporting operational activities related to the maintenance of marketing authorizations across assigned markets and submission types in European Partnership Markets.This role involves close collaboration with country leads, global regulatory teams/centers, and local 3rd party service...

What We Expect From You:Education: University degree in Life Sciences, Pharmacy, or a related field.Experience: Proven experience in regulatory affairs within the pharmaceutical industry.Language Skills: Fluency in English is required; Polish is a plus.Project Management: Strong understanding of Regulatory Information Systems, planning, and publishing...

We are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products.Key ResponsibilitiesLead the preparation of regulatory dossiers for submission to Health Authorities.Develop and execute global CMC regulatory strategy.Participate as the Regulatory CMC Lead on CMC/VST...

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 DescriptionWe are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products.This is a unique opportunity to contribute to global submission plans, refine regulatory strategies, and drive successful product development. In this position, you will lead the preparation...

The role of Associate Director, Regulatory Affairs Advertising & Promotion involves providing strategic regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products. This includes ensuring compliance with US laws and regulations, as well as company policies.The successful...

**Company Overview**GlaxoSmithKline is a global biopharma company that unites science, technology, and talent to get ahead of disease together. We positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.We prevent and treat disease with vaccines, specialty, and general medicines. Our success depends on...

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...

About the Role:We are seeking an experienced Senior Regulatory Affairs Professional to join our team and support the implementation of regional regulatory strategies for pharmaceutical products. As a key member of our team, you will collaborate closely with global and regional teams to execute regulatory submission plans, support product approvals, and...

RequirementsA college graduate in Biological Science, Public Health, Regulatory Science, or related field, or related experience; Masters or PhD preferred.A minimum of 15 years' experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (EMA).Expert knowledge of scientific principles and...

About Our TeamThe CMC Regulatory Affairs group at GSK ensures the approval and continuous supply of medicines. This team brings together operation and execution aspects for key regulatory deliverables.Key ResponsibilitiesThis position involves managing multiple CMC new files and CTA assignments, defining regulatory strategy, and delivering high-quality...

Job Description:We are seeking a skilled Pharmaceutical Sales Expert to join our team at IQVIA Argentina.About the Role:Develop and execute strategic sales plans to achieve revenue targets within the pharmaceutical industry.Work closely with clients to understand their business challenges and propose customized solutions that address their specific...

ResponsibilitiesThis role requires strong project management skills, with experience in leading audits and implementing quality assurance/control and pharmaceutical regulatory programs.You will be responsible for providing support to Operations in training staff on QMS system requirements and GDP, while also focusing on the management of authorized...

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention...

About the Role:We are seeking a highly skilled Pharmaceutical Market Expert to join our TN Poland team. As a key member of this team, you will play a critical role in driving the implementation of market access strategies for our pharmaceutical products.Your primary responsibility will be to support the achievement of business objectives through the rapid...

At GlaxoSmithKline, we are committed to getting ahead of disease together. As a Senior Regulatory Specialist, Product Variations, you will play a crucial role in this mission.Your key responsibilities will include managing multiple CMC variations and source transfers of GSK's APIs, Intermediates, and Finished Products. This involves working with the CTD...

**About the Role**We are seeking a highly skilled Regulatory Affairs Professional to join our team at GlaxoSmithKline.The successful candidate will be responsible for managing multiple CMC variations and source transfers for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for pharmaceutical, biopharmaceutical, and vaccine products....

About the RoleWe are seeking a skilled Regulatory Systems Specialist to join our team in Warsaw. As a key member of our regulatory affairs team, you will be responsible for supporting strategic and operational projects that align with business strategy and platform delivery.Your primary focus will be on leading activities to advance your career, including...

Social network you want to login/join with:Principal Regulatory Strategist (CRO/Pharma Industry) - Europe, WarsawClient:MMSLocation:Warsaw, PolandJob Category:OtherEU work permit required:YesJob Reference:29626350593cJob Views:3Posted:21.03.2025Expiry Date:05.05.2025Job Description:Are you looking to join a company where your contributions truly matter, and...

Social network you want to login/join with:(Senior) Regulatory Affairs Associate - Labelling & Artwork, WarszawaClient: ParexelLocation: Various locations - Poland, Romania, Serbia, Czechia, Hungary, and LithuaniaJob Category: OtherEU work permit required: YesJob Reference: bacd19158fbdJob Views: 3Posted: 14.04.2025Job Description:When our values align,...