Piramal Pharma Solutions Hiring Regulatory Affairs Manager

Piramal Pharma Solutions Hiring Regulatory Affairs Manager

Piramal Pharma Solutions is looking for a talented Regulatory Affairs Manager to join their dynamic team in Mumbai, Maharashtra. This position is ideal for candidates with 7+ years of experience in pharmaceutical regulatory affairs, particularly in injectable dosage forms. If you hold a Master’s degree in Pharmacy, this could be the perfect opportunity to take your career to the next level.

Job Role Overview

The Regulatory Affairs Manager will play a critical role in managing the regulatory compliance and life cycle maintenance of Piramal Pharma’s Critical Care products, especially for the USA market. You will collaborate with cross-functional teams and work closely with health authorities, country distributors, and external partners.

Key Responsibilities

• Lead post-approval product CMC changes and determine appropriate global filing strategies.
• Manage and compile documentation for product compliance, registration, and lifecycle management.
• Assist in regulatory due diligence for new business opportunities, including in-licensing and product acquisition.
• Provide strategic guidance to cross-functional teams on regulatory matters.
• Ensure compliance with ICH, WHO, GMP, USP, and US FDA regulations.

Qualifications & Experience

• Master’s degree in Pharmacy is required (Regulatory Affairs certification is preferred).
• At least 7 years of experience in pharmaceutical regulatory affairs, with a focus on injectable dosage forms.
• Hands-on experience with ANDA submissions and post-approval variations.
• Excellent knowledge of regulatory guidelines and the ability to interpret and implement them effectively.
• Strong leadership and communication skills to manage stakeholders across different teams.

Location Details

Position: Regulatory Affairs Manager
Location: Kurla, Mumbai, Maharashtra
Department: Regulatory Affairs
Travel Requirements: Low
Business Unit: Piramal Critical Care

How to Apply

If you meet the qualifications and are ready to take the next step in your career, apply today!

Apply Online: Click here to apply

Job Info
Job Identification: 6543
Category: Regulatory Affairs
Posting Date: September 16, 2024
Application Deadline: October 3, 2024
Job Schedule: Full-time
Location: Piramal Agastya Pvt Ltd., LBS Marg, Kamani Junction, Mumbai, Maharashtra, 400070