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 6 days ago

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Deputy Manager / Manager - Regulatory Affairs - (Derma) Alembic Pharmaceuticals

12.0 - 15.0 years

16 - 20 Lacs

hyderabad

Work from Office

Role & responsibilities Health Canada ANDS (Abbreviated New Drug Submission): Comprehensive knowledge of Health Canada's ANDS pathway for generic drug approvals. Skilled in compiling complete ANDS dossiers (Modules 15) and interpreting regulatory guidance. Experienced in responding to Clarifax and NSNs with scientifically robust justifications. Proficient in eCTD submissions and managing post-approval changes (Level I/II). Drug Master File (API): Expertise in DMF referencing and coordination with API manufacturers for compliant submissions. EU & UK Generic Drug Registration In-depth understanding of EMA centralised, decentralised, and MRP procedures. Skilled in MHRA regulatory pathways post-...

Posted 2 weeks ago

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Manager, Regulatory Affairs (Pre Approval) Amneal Pharmaceuticals

10.0 - 14.0 years

0 Lacs

ahmedabad, gujarat

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 2 weeks ago

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