Walk-in Interview for Regulatory Affairs Officer / Executive Post at Rusan Pharma-13th March 2025

Pharmaceuticalcarrier; Mumbai; On-site; INR 4,00,000 - 8,00,000; Full time

Job summary

A leading pharmaceutical company in Mumbai is seeking an Officer/Executive for its Regulatory Affairs team focusing on APIs. The role involves preparing regulatory submissions, collaborating with teams, and ensuring compliance with international standards. Ideal candidates will have 2-5 years of experience and an M.Sc. in Chemistry or Pharmaceutical Sciences. Join us for a walk-in interview on March 13, 2025.

Qualifications

• 2 to 5 years of experience in regulatory affairs.
• Strong understanding of API regulatory requirements.
• Familiarity with international regulatory standards.

Responsibilities

• Review and compile dossiers for API regulatory submissions.
• Prepare and submit Drug Master Files (DMFs) according to regulations.
• Collaborate with teams to gather necessary data for submissions.
• Manage regulatory queries and responses from health authorities.
• Ensure compliance with ICH, USFDA, EDQM standards.
• Maintain regulatory documentation and update records.

Skills

Regulatory submission compilation

DMF preparation

Data collaboration

Regulatory queries handling

ICH guidelines adherence

Education

M.Sc. in Chemistry or Pharmaceutical Sciences

Job description

About Rusan Pharma

Rusan Pharma Ltd., a research-driven pharmaceutical company, is seeking dynamic professionals for its Regulatory Affairs – API team. With a strong presence in India and international markets, Rusan specializes in Pharmaceutical Formulations, Active Pharmaceutical Ingredients (APIs), and Intermediates. Our state-of-the-art facilities are approved by Health Canada, EUGMP, and EDQM.

Position: Officer / Executive – Regulatory Affairs (API)

Department: Regulatory Affairs – API
Experience: 2 to 5 years
Qualification: M.Sc. (Chemistry / Pharmaceutical Sciences)

Key Responsibilities:

• Review and compile dossiers for API regulatory submissions.
• Prepare and submit Drug Master Files (DMFs) in compliance with regulatory requirements.
• Collaborate with cross-functional teams to gather data for dossier preparation.
• Handle regulatory queries and coordinate responses from global health authorities.
• Ensure adherence to ICH guidelines, USFDA, EDQM, and other international regulatory standards.
• Maintain regulatory documentation and update databases.

Walk-In Interview Details:

Date: 13th March 2025
Time: 9:00 AM – 5:00 PM
Venue: Rusan Pharma Ltd, 58D Industrial Estate, Charkop, Kandivali West

Join us and be a part of our innovative and fast-growing team!