Senior Regulatory Affairs Manager
5 days ago
Job Title: Senior Manager, Regulatory Labelling Location: UK, Fully Remote
Salary: Competitive Salary + Excellent Benefits
Employee Type: Permanent
As a Senior Manager, Regulatory Labelling, you will take leadership on everything related to Regulatory Labelling. This includes inputting from a regulatory labelling perspective on developing and established drug programs and being accountable for driving global labelling strategies. This is a challenging opportunity to demonstrate your knowledge in managing regulatory processes and supporting cross-functional teams with end-to-end labelling processes.
Be responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (EU SmPC, EU PIL, etc) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents.
Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation.
Support labeling inspection/audit readiness activities.
Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed.
Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control.
Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines.
University Degree in a scientific degree.
~ 5+ years of experience in drug development especially in labelling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
~ Electronic document management systems use and / or electronic submission experience
~ Regulatory Information Management System (RIMS), electronic document management system (EDMS). Ability to manage the review and approval of labeling in a document management system.
~ In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams
~ Fluent in English written and spoken
-
Director of Regulatory Affairs
2 weeks ago
United Kingdom VRS Regulatory Full timeA unique opportunity to take a key role on the leadership team of a highly successful and award-winning developer of naturally sourced, sustainable ingredients for regulated consumer products. They are the leader in their field, the market is exploding, this position will be paramount to this regulatory centric business’ continued global growth.The company...
-
Director of Regulatory Affairs
2 weeks ago
United Kingdom VRS Regulatory Full timeA unique opportunity to take a key role on the leadership team of a highly successful and award-winning developer of naturally sourced, sustainable ingredients for regulated consumer products. They are the leader in their field, the market is exploding, this position will be paramount to this regulatory centric business’ continued global growth. The...
-
Senior Director, Regulatory Affairs
2 days ago
York Wy, England, N AS United Kingdom Inc Full timeJoin Beacon Therapeutics (USA) Inc. as a Full-Time Senior Director of Regulatory Affairs and be at the forefront of transformative biotech innovations. This is a unique opportunity to shape regulatory strategies that directly influence the success of groundbreaking therapeutics in the UK market. Here, you will have the chance to leverage your expertise in a...
-
Senior Manager/Director of Regulatory Affairs
3 weeks ago
United Kingdom Planet Pharma Full timeRegulatory Affairs Manager This organization has a strong pipeline and portfolio across multiple therapeutic areas, and they are seeking a Regulatory Affairs Manager to join their European General Medicine Regulatory team. &##You’ll provide regional regulatory expertise, guiding strategies and submissions that shape the future of their portfolio. ...
-
Regulatory Affairs Manager
3 weeks ago
United Kingdom Planet Pharma Full time🌍 Regulatory Affairs Manager We are partnering with a global biotechnology leader that is dedicated to advancing innovative medicines and improving patient outcomes. This organization has a strong pipeline and portfolio across multiple therapeutic areas, and they are seeking a Regulatory Affairs Manager to join their European General Medicine Regulatory...
-
Regulatory Affairs Manager
1 week ago
United Kingdom - Remote Bausch Health Full time £60,000 - £100,000 per yearJoin our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.The...
-
Regulatory Affairs Manager
5 days ago
United Kingdom Atrio Search Full timeMy client is looking for a Regulatory Affairs Manager (Independent Consultant) to strengthen its European regulatory affairs team and support the registration of plant protection products in the United Kingdom.Mission 1 – Manage UK Ecotoxicology RegistrationsPrepare, submit, and maintain registration dossiers for plant protection products under the UK...
-
Regulatory Affairs Manager
5 days ago
United Kingdom Atrio Search Full timeMy client is looking for a Regulatory Affairs Manager (Independent Consultant) to strengthen its European regulatory affairs team and support the registration of plant protection products in the United Kingdom. Mission 1 – Manage UK Ecotoxicology Registrations Prepare, submit, and maintain registration dossiers for plant protection products under the UK...
-
United Kingdom Atrio Search Full timeMy client is looking for a Regulatory Affairs Manager (Independent Consultant) to strengthen its European regulatory affairs team and support the registration of plant protection products in the United Kingdom. Prepare, submit, and maintain registration dossiers for plant protection products under the UK regulatory system, liaising with the Health and...
-
Senior Manager Regulatory Affairs CMC
1 week ago
Blocks A & B, Portway Building, Granta Park, Cambridge, Suffolk, United Kingdom Bicycle Therapeutics Full time £60,000 - £120,000 per yearCompany Description Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their...
