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 [caption id="attachment_81742" align="aligncenter" width="930"] Piramal Pharma Solutions Recruitment - Job vacancies[/caption]
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 applyJob 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 https://pharmastuff.org.in/job/piramal-pharma-solutions-regulatory-affairs-manager
