Manager- Biologics RA-CMC

USV, a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India.Explore us at Function: BiologicsPosition: Deputy Manager/Manager - Regulatory Affairs (Clinical)Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working,...

One of our client based at Mumbai (Reputed MNC Company) is looking for below positionsRole & responsibilities1. Asst Manager / Manager/Sr. Manager - Biologics Regulatory Affairs (Clinical Trials)-2 positionsJob Location: Govandi (East ), Mumbai (alternate Saturday working)Desired Qualification: M.Pharm/B.PharmDesired Work Experience: 5-10 yearsJob...

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...

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...

Designation Asst Manager Global Regulatory Affairs CMC On a Contract Department Global Regulatory Affairs CMC Contract Duration 12 Months will be working on Talisman payroll Not renewable Location MIDC Andheri East Mumbai Working Day Monday To Friday Time 9 A M To 6 P M Primary Job Function 1 Product registrations Submissions -Assists...

Job DescriptionReady to shape the future of workAt Genpact, we don't just adapt to change-we drive it. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow...

Job Description – Regulatory Affairs CMC Associate (US Market) We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities. Key Responsibilities: Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format....

You will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables...

Job DescriptionThis Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance's and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products.Our...

SummaryHA (Health Authority) submissions and regulatory compliances for New Drugs, Line extension, additional indication, production transfer, site registration, renewal, CMC, PI, PSUR to ensure business continuity and support clinical trial projects under GDO and need-based support to other regulatory projects in CPO India. To oversee and drive compliance...