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

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Senior Scientific Manager - Formulations R&D Aragen Life Sciences

5.0 - 13.0 years

0 Lacs

hyderabad, telangana

On-site

Role Overview: As a Formulations Scientist in Hyderabad, India, you will be responsible for the development of oral solid dosage forms of Non-DEA and DEA substances. Your key functions will include conducting Literature Search, Pre-Formulation, Formulation Design, and Development of stable, Bioequivalent, and Manufacturable generic solid oral formulations. Key Responsibilities: - Act as a mentor and motivator to the team. - Develop robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. - Evaluate patents and develop non-infringement strategies, including the capability of developing Paragraph IV products. - Scale-up and optimize manufact...

Posted 1 month ago

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Regulatory Affairs Associate Endo

2.0 - 6.0 years

0 Lacs

indore, madhya pradesh

On-site

The Associate, Regulatory Affairs is responsible for supporting regulatory efforts related to the submission of supplemental ANDAs, ANDA Annual Reports, Drug Listing, SPL/PLR (labeling), and other regulatory compliance matters to assist the company's approved product portfolio, both internally and externally. Key responsibilities include: - Compiling and submitting Post Approval Supplements such as PAS, CBE-0, CBE-30. - Preparing, reviewing, and submitting amendments and supplements for assigned products. - Preparing, reviewing, and submitting responses to the Agency's queries for assigned products. - Compiling and submitting Global Annual Reports. - Reviewing stability protocols and reports...

Posted 2 months ago

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Regulatory Affairs Specialist - CMC (USFDA) vueverse.

7.0 - 11.0 years

0 Lacs

hyderabad, telangana

On-site

As a Regulatory Affairs Manager specializing in CMC, you will be responsible for leading and managing all CMC regulatory activities related to USFDA submissions, specifically focusing on ANDA preparation, review, and filing. Your role will involve overseeing the compilation and timely submission of Annual Reports, amendments, and responses to deficiencies. You will collaborate with cross-functional teams such as Quality Assurance, Production, and R&D to gather the necessary documentation and data required for regulatory submissions. A significant aspect of your responsibilities will include reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, ...

Posted 2 months ago

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Sr. Associate - Regulatory Affairs (CMC) Endo

3.0 - 7.0 years

0 Lacs

jharkhand

On-site

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Pr...

Posted 3 months ago

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