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Assistant Manager - Regulatory Affairs (Post Approval) @ Leading Pharma Client

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 Assistant Manager - Regulatory Affairs (Post Approval)

Job Description

Role & responsibilities

Review of post approval changes and evaluating its impact on the products.

Preparation of appropriate post approval submissions such as PAS, CBE 30 & 0, and annual reports.

Management of product life cycle.

Managing Team

Dosage Form : Solid Oral / Nasal / Liquid/ Ophthalmics


Preferred candidate profile

10+ Years of USFDA post approval submission experience

USFDA Experience

Exposure to ANDA /NDA post approval submissions


Please share updated CV on hr*9@he************k.com


Job Classification

Industry: Pharmaceutical & Life Sciences
Functional Area / Department: Legal & Regulatory
Role Category: Legal & Regulatory - Other
Role: Legal & Regulatory - Other
Employement Type: Full time

Contact Details:

Company: Leading Pharma Client
Location(s): Mumbai

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Keyskills:   USFDA Regulatory Affairs Regulatory Submissions

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₹ 18-20 Lacs P.A

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Leading Pharma Client

Leading Pharma Client