Regulatory Submission Strategy Lead

We're looking for an experienced Regulatory Operations professional to join our team at Novartis Farmacéutica. In this role, you'll lead and manage multiple global regulatory submissions in eCTD and non-eCTD formats, and develop strategies to ensure compliance with HA requirements.About the Company OverviewAt Novartis Farmacéutica, our purpose is to...

A sought-after Vice President Scientific Affairs and Regulatory Engagement position is available at a pioneering pharma company in Switzerland. Reporting to the Senior Vice President Research & Development, you will drive the scientific strategy and ensure regulatory compliance for all products. Key areas of focus include leading the Council of Fellows,...

Job Title: Head of Medical Writing and Regulatory SubmissionsA leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors seeks to advance medical research and support the development of transformative therapies through excellence and innovation.Position Overview:We are hiring a...

We are seeking a talented individual to join our team as a Head of Medical Writing and Regulatory Submissions. This senior-level position involves overseeing the production of high-quality regulatory submissions and medical documents. The successful candidate will have excellent leadership skills and experience in managing teams.Key Qualifications and...

Role OverviewA challenging opportunity has arisen for a Regulatory Affairs Strategist to join VRS Regulatory's team. About the RoleWe are seeking an experienced Regulatory Affairs Strategist to develop and implement regulatory strategies for plant protection products in specific geographical territories. Develop and execute regulatory strategies for product...

Lead Global Regulatory SubmissionsTake charge of multiple, simultaneous eCTD and non-eCTD format submissions across the globe. Utilize your expertise to drive cross-functional teams toward strategic planning, compilation, and dispatch of worldwide HA submissions. Develop creative solutions to anticipated technical challenges and manage the effective...

Job DescriptionThe successful Health Economics Manager will have experience of designing and implementing launch HTA submissions for new products into the UK&I markets. They will work cross-functionally with medical, commercial, and regulatory teams to develop the Product, Reimbursement, Price strategy, and HEOR.

Role Overview:Barrington James is seeking an exceptional Senior Medical Writing and Regulatory Submissions Specialist to lead our Medical Writing and Regulatory Affairs department. As a key member of our team, you will be responsible for overseeing the preparation and delivery of high-quality regulatory submissions and medical writing outputs, ensuring...

The Global Regulatory Strategy Manager role at ICON plc involves leading regulatory operations activities, developing strategies for regulatory submissions and approvals, and collaborating with cross-functional teams to provide regulatory guidance and support throughout the drug development process.About the Team:Work with a diverse and dynamic team of...

Job DescriptionAs a CMC Regulatory Strategy Manager at Vertex, you will be responsible for developing and executing global regulatory CMC strategies for investigational and commercial products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory requirements.ResponsibilitiesReview Regulatory Submissions:...

Cranleigh Scientific Ltd seeks a seasoned Regulatory Affairs Strategy Manager to drive compliance and strategy for our veterinary diagnostic products. This role is critical in ensuring we meet regulatory requirements, with a strong focus on the EU and USA.The ideal candidate will have 7-10 years of experience in regulatory affairs, with a proven track record...

About the CompanyGSK is a leading global biopharma company with a long history of innovation and commitment to improving patient outcomes.We are seeking a highly experienced and skilled Global Regulatory Affairs Director to join our team in this exciting role. The successful candidate will be responsible for developing and executing global and regional...

Job TitleRegulatory Affairs Lead (#J-18808-Ljbffr)About the CompanyAdvanced Accelerator Applications (Italy) - S...Job DescriptionThe Senior Regulatory Affairs Manager is a key member of our team, responsible for all aspects of submission, approval and life-cycle management of assigned Marketing Authorisations (MAs). They provide effective regulatory support...

About the PositionWe are seeking a highly experienced Global Regulatory Chemistry Lead to join our team at Vertex. In this role, you will be responsible for leading global regulatory chemistry efforts, including developing and executing strategies, reviewing regulatory submissions, and providing regulatory guidance.Key ResponsibilitiesLead Regulatory...

Barrington James, a prominent clinical trials sector organisation, is seeking a highly experienced Director of Medical Content and Regulatory Strategy. This role offers the opportunity to lead and manage teams within a dynamic, research-driven environment focused on advancing medical innovation and supporting the development of transformative therapies.The...

About the RoleLifelancer, a leading talent-hiring platform in Life Sciences, Pharma and IT, is seeking an experienced Clinical Trials Regulatory Specialist to join their team. This role will focus on clinical trial submissions for the EU region, utilizing the CTIS system.Responsibilities: Ensure compliance with EU Clinical Trials Regulation for clinical...

ResponsibilitiesThis challenging role requires a skilled professional who can lead interactions with local/regional regulatory authorities, work closely with commercial teams to secure the best possible labelling commensurate with the available data, and proactively develop regulatory strategies that meet the needs of the local region(s).The ideal candidate...

Role Summary: We are seeking an experienced Health Economics Manager to join our team, who can provide expert advice on market access and HTA submissions.Key Responsibilities: The successful candidate will have in-depth knowledge and understanding of the UK&I pricing and reimbursement policies, and will lead the HTA submission process and strategies to...

Regulatory Strategy Lead - CMCBarrington James Limited is seeking a highly skilled Regulatory Strategy Lead to join our team in London. As a key member of our consultancy, you will provide expert guidance on CMC aspects of product development, working closely with clients to achieve their goals.Estimated Salary: £80,000 - £110,000 per annumJob...

About VixioVixio is a leading Regulatory Technology (RegTech) platform that helps businesses navigate the complexities of regulatory compliance in the payments and gambling industries.