Manager, Regulatory Affairs (Pre Approval) Amneal Pharmaceuticals

10.0 - 14.0 years

0 Lacs

ahmedabad, all india

On-site

Role Overview: As a Regulatory Affairs Specialist at the company, your main responsibility will be to prepare, review, and finalize regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, DDCP, etc., along with 505(b)(2) products for regulated markets like the US, Canada, and EU. You will be drafting, reviewing, and finalizing various regulatory documents including Pre-ANDA/Pre-IND/ScA/Scientific meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will collaborate with cross-functional teams, meet management expectations regarding timelines and quality, and provide training to new team members o...

Posted 5 days ago

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

3.0 - 7.0 years

0 Lacs

ahmedabad, all india

On-site

Role Overview: As a Regulatory Affairs Specialist at our company, your role involves preparing regulatory strategies for complex products such as injectables, peptides, microspheres, liposomes, nano-suspensions, ophthalmic, otic, topical gel, DDCP, etc., as well as 505(b)(2) products for the US and EU markets. You will be responsible for drafting Pre-ANDA/Pre-IND/ScA meeting packages, controlled correspondences, and deficiency responses for complex products and 505(b)(2) products. Additionally, you will review API and FP in-vitro characterization/sameness reports, as well as DMF reviews for complex APIs, while collaborating closely with cross-functional teams. Key Responsibilities: - Prepare...

Posted 5 days ago

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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 2 months ago

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