Pharmaceutical Regulatory Consultant Trinite Consulting

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

As an experienced Regulatory Affairs Consultant with specialized knowledge in lipid-based pharmaceutical products, particularly Fish Oil Triglycerides such as EPA/DHA omega-3 fatty acids, your role will involve providing regulatory support and strategic guidance for drug, dietary supplement, or nutraceutical products containing fish oil derivatives to ensure compliance with global regulatory standards including FDA (CDER & CFSAN). You will be a crucial resource within the organization, offering technical expertise and regulatory guidance for the development, manufacturing, and commercialization of lipid-based pharmaceutical products. Your role will require strong cross-functional collaborati...

Posted 1 month ago

AI Match Score

Apply

Regulatory Consultant Metina PharmConsulting

8.0 - 12.0 years

0 Lacs

navi mumbai, maharashtra

On-site

The person will be responsible for project specific regulatory consulting services at the firm. You will have complete ownership of all regulatory projects, including dossier writing, submissions, approval tracking, and query resolution across Developed and Emerging markets. Your role will involve ensuring regulatory compliance, accuracy, timely completion, version control, and adherence to internal SOPs. Additionally, you will provide strategic input to the Management and Partners on regulatory projects. It is essential to keep abreast of new developments in regulations across all critical health authorities. The ideal candidate should have formal regulatory affairs experience for a minimum...

Posted 2 months ago

AI Match Score

Apply

Regulatory Affairs US- Executive / Sr Executive Unichem Laboratories Limited

5.0 - 11.0 years

0 Lacs

maharashtra

On-site

You should have a minimum of 5-11 years of experience in authoring high-quality CMC documentation for US FDA submissions, including Original ANDA/Deficiency responses/Post approval supplements/Annual reports. Your responsibilities will include identifying required documentation for US regulatory submissions, ensuring technical congruency and regulatory compliance, reviewing and identifying content issues with source documents, and keeping knowledge up to date with regulatory guidelines. You must have a B. Pharm/M. Pharm qualification and possess hands-on experience with eCTD software, as well as a strong understanding of CTD/eCTD requirements for submission of dossiers. Additionally, you sho...

Posted 3 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.