Manager-Biologics Regulatory Affairs(Clinical Trials)

Job Title:Biologics Regulatory Affairs Specialist (Clinical Trials)About the Role:We are seeking a skilled Biologics Regulatory Affairs Specialist to oversee the regulatory aspects of our clinical trials for EU and US markets.The ideal candidate will have hands-on experience in developing biosimilar clinical development strategies, clinical trials, and...

Job SummaryWe are seeking an experienced Regulatory Affairs Specialist to join our team in the Biologics department. This role involves developing and executing clinical trials strategies for EU and US markets, with a focus on biosimilars.

Biologics Regulatory Affairs Job OverviewThis role involves strategic planning, execution and delivery of biologics clinical trials across EU and US markets. The ideal candidate will possess expertise in biosimilar clinical development, regulatory affairs, and eCTD submissions.About the RoleThe successful candidate will be responsible for developing and...

Regulatory Affairs SpecialistMain Purpose of Role:We are seeking a highly experienced and knowledgeable Regulatory Affairs Specialist to join our team. The ideal candidate will have comprehensive knowledge in the area of Regulatory Affairs and be able to execute complex projects.The Regulatory Affairs Specialist will direct the development of product...

Job DescriptionPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile...

Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile will ensure...

Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...

We are seeking an experienced Regulatory Affairs professional to join our organization.The successful candidate will be responsible for ensuring compliance and successful product approvals by applying subject matter expertise in Regulatory Affairs.Key Responsibilities:Lead the preparation and submission of product registration documents, progress reports,...

About This RoleThis Regulatory Affairs position is focused on the development and execution of regulatory strategies for complex products.The incumbent will be responsible for ensuring compliance with regulatory requirements across multiple markets, including the US, Europe, and UK.Specifically, this role involves:Regulatory Compliance: Ensuring adherence to...

Medpace is currently looking forClinical Trial Manager (CTM)to lead global clinical research studies. This position is fully office-based in our Mumbai, India office. Medpace is a scientifically led organization involved in full services for our clients, giving the Medpace project teams the empowerment to truly lead and execute clinical...