Deputy Manager, Regulatory Affairs

Amneal Pharmaceuticals · Gujarat

Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.
Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
Draft and finalize controlled correspondences on complex issues.
Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products.
Review API and FP in-vitro characterization/sameness reports.
DMF review for complex APIs as per the workflow.
To collaborate and work closely with cross functional teams.
To meet the management expectations w.r.t timelines and quality.
To work closely within the team and provide training to new members on new regulatory requirements for Complex products.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. Candidate with Master's degree in Pharmacy, minimum 8-10 years experience in regulatory affairs injectable dosage form, hands on experience in submission of ANDA and deficiency responses for US market. Additionally candidates with experience in submission of meeting packages to US FDA is preferred.

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