Regulatory affairs executive

**Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...

About the RoleParexel is seeking a highly skilled Regulatory Affairs professional to join our team. As a Regulatory Affairs Consultant, you will be responsible for managing the pre- and post-approval life cycle of biologic products in various markets, including regulated (EU/US/Canada) and emerging markets.Key ResponsibilitiesDevelop and implement regulatory...

Summary:The Regulatory Affairs Officer ensures that pharmaceutical products comply with industry regulations. This role involves preparing and submitting regulatory documents, managing compliance, and maintaining product approvals.Roles and Responsibilities:Regulatory Submissions: Prepare and submit regulatory documents for product approvals and...

Director of Regulatory Affairs and Clinical TrialsWe are seeking a highly experienced Director to lead our regulatory affairs and clinical trials team.About the RoleThis is a senior leadership position that will oversee the strategic direction of our regulatory affairs and clinical trials operations.Key ResponsibilitiesProvide strategic guidance on...

Regulatory Affairs at Baxter: A Key Role in Delivering Innovative Healthcare SolutionsBaxter, a leading medical products company, is seeking a talented Regulatory Affairs Specialist to join its team. In this crucial role, you will play a key part in ensuring the company's products meet the highest regulatory standards, enabling us to deliver innovative...

About the RolePhilips is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for the US, EU, and RoW.Key...

Company OverviewLifelancer is a leading talent-hiring platform in the Life Sciences, Pharma, and IT sectors. Our mission is to connect top talent with opportunities in these fields. Job Title: Regulatory Affairs ManagerSalary: $120,000 - $180,000 per yearLocation: Remote or On-Site (Flexible)Job Description:We are seeking an experienced Regulatory Affairs...

JOB TITLE : Regulatory Affairs Executive - ROW marketsWHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES?As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training that teaches coaching skills, team collaboration,...

Responsible for collating and compiling the dossiers for filing in different International markets like Africa, Asia, Latam, CIS & EU markets as per Relevant Regulatory guidelines of Pharmaceutical dosage forms like Tablets/Capsules/Dry syrup/Liquid syrup/Sterile Injectables (powder & liquid) /Ophthalmic/Semi solid preparations. Co-ordinating with...

Job Description Overview:ScaleneWorks seeks a skilled Regulatory Affairs Specialist to lead our regulatory efforts. As a key member of the team, you will be responsible for ensuring the compliance of our products with relevant regulations.About the Role:This is an exciting opportunity to join ScaleneWorks as a Regulatory Affairs Specialist. You will be...

Job Title: Regulatory Affairs LeadAt Indegene, we are seeking a highly skilled Regulatory Affairs Lead to join our team. This role will be responsible for ensuring compliance with regulatory requirements for medical devices worldwide.Key Responsibilities:Disseminate regulatory intelligence and coordinate with stakeholders to ensure compliance.Assess...

Job Title: Principal Regulatory Affairs SpecialistJob Description:Key Responsibilities:Develop and execute regulatory strategies for new product development, design changes, and field safety corrections for US, EU, and RoW.Author 510k submissions, lead pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications, and lead...

Job TitleAssociate Director, Regulatory AffairsAbout the RoleParexel is seeking an experienced Associate Director, Regulatory Affairs to join our team. The ideal candidate will have a strong background in clinical trial regulatory submissions and leadership experience in managing clinical trial studies.Clinical Trial Regulatory Submissions: Over 15 years of...

Job DescriptionAmazon Kuiper Services India Private Limited - Q38 is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Global Regulatory Affairs team, you will play a critical role in enabling and protecting Kuiper's use of radio frequency spectrum and satellite orbits worldwide.About the RoleThe successful...

JOB TITLE :Regulatory Affairs Executive - ROW marketsWHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES?As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training that teaches coaching skills, team collaboration,...

The Regulatory Affairs function at ResMed plays a crucial role in ensuring compliance with regulatory frameworks and delivering optimal regulatory strategies for portfolio planning, active regulatory intelligence, and excellence in execution.Key Responsibilities:Support and maintain internal and government databases relevant to ResMed's operations.Define and...

Job Title Principal Regulatory Affairs Specialist About the RoleWe are seeking a seasoned Regulatory Affairs professional to lead our efforts in ensuring compliance with global regulations and standards for medical devices. As a key member of our team, you will be responsible for developing and executing regulatory strategies for new product development,...

**Job Title:** Regulatory Affairs ProfessionalAbout the Role:We are seeking an experienced Regulatory Affairs Professional to join our team at Apotex. As a key member of our Regulatory Affairs department, you will be responsible for preparing and submitting regulatory documents, including drug master files, amendments, and annual reports.Key...

Regulatory Affairs LeadThe ideal candidate for this role will be a highly organized and detail-oriented individual with a strong background in Medical Device Regulations. As a Regulatory Affairs Lead at Indegene, you will be responsible for ensuring compliance with global regulations and facilitating the registration of medical devices.Key...

Job Title: Global Biosimilars Regulatory Affairs SpecialistDescription:We are seeking a highly skilled Global Biosimilars Regulatory Affairs Specialist to join our team at Biocon Biologics.As a Global Biosimilars Regulatory Affairs Specialist, you will be accountable for the development and execution of CMC regulatory strategies, marketing applications, and...