Senior Executive, Regulatory Affairs, Pre Approval Injectable USA Market Amneal Pharmaceuticals

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

Role Overview: As a Regulatory Affairs Specialist at Amneal, your primary responsibility will be to prepare regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, and 505(b)(2) products for both the US and EU markets. You will be drafting Pre-ANDA/Pre-IND/ScA meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will review API and finished product in-vitro characterization reports, collaborate with cross-functional teams, and ensure compliance with regulatory standards. Key Responsibilities: - Prepare Regulatory strategies for Complex Products including injectables, peptides, microspheres, lipos...

Posted 3 weeks ago

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NDDS Injectable Formulation & Development - Research Associate Intas

2.0 - 5.0 years

4 - 7 Lacs

ahmedabad

Work from Office

Job Purpose: To lead and execute formulation development of Novel Drug Delivery Systems (NDDS) in the injectable segment, including liposomes, microspheres, nanoparticles, depot injections, and other complex injectable formulations for regulated and semi-regulated markets. Key Responsibilities: Design and develop NDDS injectable formulations such as liposomes, emulsions, microspheres, suspensions, nanoparticles, and depot systems. Conduct pre-formulation and formulation studies, compatibility studies, and risk assessments. Execute lab-scale and scale-up batches as per QbD principles and DoE designs. Evaluate and finalize suitable processes, components, and primary packaging materials. Ensure...

Posted 1 month ago

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Research Chemist Organic Chemistry Flychem

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

As a highly skilled and experienced Research Chemist with a Master's degree in Organic Chemistry and at least 5 years of hands-on experience in laboratory research and development, your expertise in organic synthesis, process development, and delivery system optimization will play a crucial role in supporting innovative R&D initiatives, lab-scale synthesis of active ingredients, and enhancing formulation and delivery systems for cosmetic or specialty chemical applications. Key Responsibilities: - Perform multistep organic synthesis and optimize reactions on a lab scale - Operate and maintain various lab reactors including glass, stainless steel, and jacketed reactors - Handle and calibrate l...

Posted 1 month ago

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Regulatory Affairs -ROW (Assistant Manager) Sai Placement

8.0 - 13.0 years

7 - 14 Lacs

Ahmedabad, Surat, Vadodara

Work from Office

Hands on Experience on Regulatory Affairs of various ROW markets. Lead the team for day to day RA activity. Required Candidate profile Experience of working on Liposomes/Pegylated Liposomes/Microspheres/Resomer baseddepot/Dual chamber based components / Particle size based delayed drug delivery injectables/Lyophilised dosage forms.a

Posted 4 months ago

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