Assistant Regulatory eCTD Publishing Manager Fresenius Medical Care

5.0 - 9.0 years

0 Lacs

all india, gurugram

On-site

As a Regulatory Operations Assistant, your role will involve supporting daily operational activities within Regulatory Operations for preparing regulatory submissions required to market pharmaceutical products in domestic and international markets. You will be responsible for maintaining systems to ensure compliance with electronic submission requirements and document management systems. Additionally, you will lead and support the creation, implementation, and maintenance of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and operational processes in alignment with regulatory requirements and best practices. Key Responsibilities: - Serve as a seasoned regulatory o...

Posted 1 week ago

AI Match Score

Apply

Assistant Regulatory eCTD Publishing Manager Fresenius Medical Care

5.0 - 7.0 years

0 Lacs

gurgaon, haryana, india

On-site

PURPOSE AND SCOPE: Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals products in the domestic and international markets as assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems. In addition to publishing responsibilities, this role will lead and support the creation, implementation, and ongoing maintenance of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and operational processes, ensuring alignment with evolving regulatory requirements, internal...

Posted 2 weeks ago

AI Match Score

Apply

Manager-Biologics Regulatory Affairs (Clinical Trials) USV PRIVATE LIMITED

5.0 - 15.0 years

0 Lacs

maharashtra

On-site

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 for EU and US markets. - Designing and developing clinical protocols for Biosimilar Clinical trials, ensuring review and finalization for EU and US markets. - Handling Biosimilar Clinical Trial Applications, providing an overview of clinical study conduct, reviewing Clinical Study reports, and finalizing them for EU and US markets. - Aut...

Posted 2 months ago

AI Match Score

Apply

Biologics Regulatory Affairs Manager USV PRIVATE LIMITED

5.0 - 15.0 years

0 Lacs

maharashtra

On-site

You will be joining USV Private Limited, a leading pharmaceutical company in India known for its expertise in the diabetes and cardio sectors, with a global presence in over 65 countries. Your role will be in the Biologics function, specifically as an Assistant Manager or Manager in Regulatory Affairs (Clinical Trials) focusing on the EU and US markets. You will be based in Govandi (East), Mumbai, with a work schedule that includes working on the 1st, 3rd, and 5th Saturdays, while having the 2nd and 4th Saturdays off. To be considered for this position, you should have a qualification of M.Pharm/B.Pharm along with 5-15 years of relevant work experience in Regulatory Affairs-Clinical Trials f...

Posted 4 months ago

AI Match Score

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.