9 Ectd Submissions Jobs

About UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter Expert (SME) with 58 years of experience in the pharmaceutical or life sciences industry . The ideal candidate will provide strategic and operational expertise in global and regional regulatory requirements and submissions . This role involves collaborating with cross-functional teams across clinical, CMC, medical, and quality functions to ens...

About the Company 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. We specialise in niche product areas across international markets, including Oral Solid Dosages (OSD), sterile products, peptides, biologics, and oncology. USV's Biologics function is fully integrated to develop high-quality biosimilars that can cater to regulated and other markets. Currently the biosimilar pipeline includes bacterial therapeutic proteins and MAbs (monoclonal antibodies). Explore us at : www.usvindia.com About the Role Function: Biologics, Regulatory Affairs Positio...

As a Drug Regulatory Affairs Specialist, you will play a crucial role in developing and implementing regulatory strategies to bring drugs to market in compliance with relevant laws and regulations. Your responsibilities will include conducting regulatory research, providing guidance on regulatory issues, and preparing and submitting applications and regulatory submissions such as INDs, NDAs, and BLAs. You will also be tasked with communicating with regulatory agencies, managing projects and timelines, and collaborating with cross-functional teams to ensure regulatory compliance throughout the product development process. It is essential for you to stay informed of regulatory changes and tren...

As a Senior Manager in Regulatory Affairs at our company, your role will involve the following responsibilities: - Act as a regulatory lead and take charge of all regulatory affairs projects - Execute and ensure timely delivery of all regulatory affairs projects - Assist in drafting and compiling dossiers for submission in various markets - Conduct quality checks on all outputs from the regulatory affairs team - Manage and oversee all regulatory submissions made by the team - Communicate project status updates to clients and the Head of Regulatory Affairs - Provide mentorship to less experienced or new team members Qualifications Required: - You should have a total of 10 to 15 years of regul...

You will be responsible for the following key activities in the role of Asst Manager / Manager - Regulatory Affairs (Clinical Trials) for EU and US markets at USV Private Limited: Role Overview: You will be part of the Biologics function at USV Private Limited and will focus on Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets. Key Responsibilities: - Develop Biosimilar Clinical design and Protocol for EU and US markets. - Manage Biosimilar Clinical Trial Application, including the overview of clinical study conduct and finalization of Clinical Study reports for EU and US markets. - Author and review Biologics/Biosimilar Dossiers, and handle eCTD su...

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...

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...

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...

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...