Officer / Sr. Officer Regulatory Affairs (API)

Harman Finochem; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Harman Finochem Ltd in Mumbai, India, is seeking an experienced Regulatory Affairs professional specializing in active pharmaceutical ingredients (API). You will compile and submit DMFs to global authorities, respond to deficiency letters, and manage lifecycle activities to keep DMFs up to date.

The role requires 2-6 years in API regulatory affairs, with experience in USDMF, EDQM CEP, Health Canada, EU-ASMF and related guidelines.

Qualifications

• 2–6 years of experience in regulatory affairs API in DMF-related work.
• Experience with USDMF, EDQM CEP, CADIFA - Brazil, Health Canada, EU-ASMF is preferred.
• Knowledge of current regulatory guidelines and ICH guidelines.

Responsibilities

• Compilation and submission of DMF to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and EU countries
• Submission of DMF amendments and variation filings to implement post-approval changes
• Evaluation of change controls and regulatory assessment based on DMF submissions
• Coordinate with QA, QC, production, ADL and R&D for registrations
• Maintain regulatory database following best regulatory practices
• Prepare action plans for deficiency letter responses and timely responses
• Provide best-in-class API regulatory support to customers
• Knowlege of current regulatory guidelines and ICH guidelines

Skills

Regulatory affairs API

DMF compilation

Health authority communications

Job description

Role & responsibilities

• Compilation and submission of Drug Master File (DMF) to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and for EU countries
• Submission of DMF amendments and variation filings to implement the post approval changes
• Evaluation of change controls and perform regulatory assessment based on submitted DMF
• Co-ordinated with cross functional team such as QA, QC,production, ADL and R&D and review of documents received for registration purpose.
• To Maintain regulatory database by following best regulatory practices
• To prepare action plan for Defficiency letter response and timely Respond to defficiency letters
• To provide Best in class API regulatory support to Customer
• Knowlege of current regulatory guidelines and ICH guidelines

Please Note: Only candidates with relevant API regulatory experience will be considered

Preferred candidate profile

• Candidate with minimum 2-6 years of experience in regulatory affairs API, for compilation of USDMF, EDQM CEP, CADIFA - Brazil, Health Canada, EU-ASMF.
• Life cycle management of DMF to keep the DMF up to Date. To respond to Health Authorities deficiency letter for successful approval of MAA.