Senior Regulatory Affairs Specialist- Clinical

Global Regulatory Affairs Manager · We're currently seeking a Global Reg Affairs Manager for an award-winning pharma company specialising in OTC products. Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core com ...In the context of our growing activities, we are looking for a Regulatory...

Job SummaryWe are seeking a highly experienced Senior Regulatory Affairs Specialist to join our team at Organon. As a key member of our Regulatory Affairs department, you will be responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned products in accordance with global regulations and guidance.Develop and...

Regulatory Affairs Specialist, IQVIA Biotech Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions: - Acts as a Regulatory Team Member on...

Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Adecco. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key Responsibilities:Handling of all post-approval activities related...

Job Title: Regulatory Affairs SpecialistAbout the Role:We are currently recruiting for a Regulatory Affairs Specialist to join our team at Adecco. As a Regulatory Affairs Specialist, you will be responsible for handling all post-approval activities related to Abbreviated New Drug Applications (ANDAs), Marketing Authorizations Applications (MAA), Abbreviated...

Senior Associate Regulatory Affairs (1-year fixed-term contract) in Lisbon , Portugal HOW MIGHT YOU DEFY IMAGINATION?THE AMGEN CAPABILITY CENTER IN LISBON, PORTUGAL (ACCP ) will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross-functional capabilities, including Commercial, General and Administrative,...

Job Title: Regulatory Affairs SpecialistAt AbbVie, we are committed to discovering and delivering innovative medicines and solutions that solve serious health issues. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the maintenance of Marketing Authorisations for medicinal products and Medical Devices registrations.Key...

Are you an experienced professional in EU Market Regulatory Affairs looking for a new challenge? We are currently recruiting for a Regulatory Affairs Specialist to join our team at Adecco.Key Responsibilities:- Handling of all post-approval activities related to Abbreviated New Drug Applications (ANDAs), Marketing Authorizations Applications (MAA),...

Job SummaryAbsorb the challenge of ensuring regulatory compliance for medicinal products and medical devices at AbbVie. As a Regulatory Affairs Specialist, you will be responsible for maintaining marketing authorizations, reviewing promotional materials, and liaising with regulatory authorities.Key ResponsibilitiesMaintain awareness of current and new...

Medical Affairs Role at Gilead Sciences, Inc.Gilead Sciences, Inc. is seeking a Medical Affairs Specialist to join our team. As a Medical Affairs Specialist, you will be responsible for responding to clinical inquiries regarding marketed or developmental Gilead products, presenting scientific and clinical data for these products, and establishing strong...

Job SummaryAbbVie is seeking a highly skilled Regulatory Affairs Specialist to ensure the maintenance of Marketing Authorisations for medicinal products and Medical Devices registrations. The ideal candidate will have a strong background in regulatory submissions, including label, artwork, and local prescribing information.Key ResponsibilitiesReview and...

Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Adecco Prestação De Serviços, Lda. The ideal candidate will have a strong background in EU Market Regulatory Affairs and be able to handle all post-approval activities related to Abbreviated New Drug Applications (ANDAs), Marketing Authorizations Applications...

**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering...

Join AbbVie's Team of Regulatory ExpertsAbbVie is a leading pharmaceutical company dedicated to discovering and delivering innovative solutions for serious health issues. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring the maintenance of Marketing Authorisations and Medical Devices registrations.Main Responsibilities:Ensure...

Job DescriptionAt Phiture, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring the maintenance of Marketing Authorisations for medicinal products and Medical Devices registrations, through variations and other regulatory submissions.Main Responsibilities:Review and ensure...

Founded in Jordan more than 40 years ago by Samih Darwazah, Hikma's purpose is to provide affordable, quality medicines to the people needing it.Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.Hikma is a multinational company with 31 plants located in...

.Corporate Affairs Senior Specialist (Policy, Communications and Patient Advocacy)Are you a Corporate Affairs specialist with experience in Policy, Communication, and Patient Advocacy who wants to take part in making the world a better place? Do you have an agile approach, creative mindset, and can-do attitude? Then you might be a good fit for us!We are...

Your JobAs a Regulatory Affairs Specialist for Global Labelling, you will be responsible for the preparation and revision of informative texts for healthcare professionals and patients in EU and non-EU markets. This includes the development of target product/labelling profiles and the management of CCDS/CCSI/RSI creation and maintenance. You will also be...

Join Our Team as a Senior/Principal Medical WriterAbout the RoleWe are seeking a highly skilled Senior/Principal Medical Writer to join our team at Trilogy Writing & Consulting. As a key member of our clinical development team, you will be responsible for producing high-quality regulatory documentation for the international pharmaceutical industry.Key...

Your JobKey ResponsibilitiesDevelop and maintain high-quality labelling and regulatory submissions for pharmaceutical products in EU and non-EU markets.Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.Manage the creation and maintenance of regulatory documents, including CCDS/CCSI/RSI, and...