Senior Biologics Regulatory Affairs Specialist

About USV Private Limited:USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.Function: BiologicsPosition: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday...

Regulatory Affairs SpecialistJob Description:We are seeking a detail-oriented Regulatory Affairs Specialist to support end-to-end submissions for global markets. This role involves exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key Responsibilities:Prepare Variation documents and/or evaluate...

Job Title: Chief Regulatory Compliance OfficerAbout the Job:The Senior Manager Regulatory Affairs is a key member of our team, responsible for leading and supervising professionals within the Regulatory Affairs Sub-Function. This role focuses on mentoring, coaching, and coordination to ensure timely approval of new drugs, biologics or medical devices and...

Job DescriptionJob Description :Business: Piramal Critical CareDepartment: Regulatory AffairsLocation: KurlaTravel: LowJob OverviewThe Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities,...

Regulatory Affairs SpecialistThe role involves the compilation, submission and management of regulatory documentation for assigned projects.Responsibilities include maintaining accurate database records pertaining to products, in line with established systems and processes.Supporting and coordinating regulatory affairs projects, as assigned, including tender...

Regulatory Affairs ProfessionalJob Overview:We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.Main...

Regulatory Affairs ManagerOur organization seeks a seasoned Regulatory Affairs professional to spearhead regulatory projects, develop innovative compliance strategies, and ensure timely product approvals.Key Responsibilities:Prepare and submit product registration dossiers, supplements, amendments, progress reports, and periodic experience reports.Interact...

Job DescriptionJob Description :Business: Piramal Critical CareDepartment: Regulatory AffairsLocation: KurlaTravel: LowJob OverviewThe Executive Regulatory Affairs is responsible for theportfolio of Piramal Critical Care/Piramal Pharma Ltd products in the ROW and Latam region(s). He/She will be the primary point of contact with the manufacturingsite in the...

Senior Quality Assurance and Regulatory Affairs LeaderWe are seeking a highly experienced and visionary professional to lead our Quality Assurance and Regulatory Affairs team in India.This senior leadership role is responsible for ensuring compliance with medical device regulations and global quality standards, while building and executing a long-term...

Regulatory Affairs LeaderSr Manager Regulatory Affairs responsible for developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance, and acting as a key liaison with regulatory agencies.Key Responsibilities:Submission Management:Preparing, reviewing, and submitting regulatory documentation to...