Ipca Laboratories Jobs Regulatory Affairs Executive | Mumbai

Ipca Laboratories Jobs Regulatory Affairs Executive | Mumbai

Ipca Laboratories, a leader in healthcare and pharmaceuticals, is seeking an experienced Regulatory Affairs Executive for its Mumbai location. This role is ideal for candidates with a strong background in USA market regulations, ANDA, and dossier preparation.

Regulatory Affairs Jobs in Mumbai

About Ipca Laboratories

Established as a reputed player in the pharmaceutical and healthcare sector, Ipca Laboratories is known for its commitment to quality, safety, and regulatory compliance. With operations in over 120 countries, Ipca plays a vital role in delivering essential medicines globally. This opening for a Regulatory Affairs Executive represents a great opportunity for skilled candidates to contribute to product compliance and quality assurance for the U.S. and other regulated markets.

Job Overview: Regulatory Affairs Executive

Location: Mumbai, Maharashtra
Job Type: Full-time, On-site
Position: Regulatory Affairs Executive (Formulation for USA Market)

The Regulatory Affairs Executive will join the team focusing on formulation regulatory affairs specifically for the U.S. market. This involves ensuring all regulatory submissions are compliant with the latest FDA guidelines and that the company maintains the highest standards of product quality and safety.

Key Responsibilities

In this role, you will be expected to:

• Preparation of registration dossiers as per the US Regulatory guideline
• Preparation of renewal application as per Renewal guidelines
• Facilitate query response raised by regulatory authority and customers
• Preparation and submission of Safety, Quality & Administrative variations as per variation guidelines

Qualifications

Education:

• B.Pharm or M.Pharm degree is required.

Experience:

• 4-7 years of experience working in regulated markets such as the USA, Europe, or Australia.
• Preferred experience with ANDA filings for the U.S. market.

Skills:

• Strong understanding of FDA guidelines and regulatory requirements for the U.S. market.
• Proficiency in dossier preparation, regulatory documentation, and response coordination.
• Detail-oriented and capable of managing complex regulatory submissions.

How to Apply

Ready to take the next step in your Regulatory Affairs career? Apply today for the Regulatory Affairs Executive position with Ipca Laboratories in Mumbai! Submit your application through LinkedIn by visiting this link.