Regulatory Affairs Executive at Ipca Laboratories, Pharma Apply
Looking for an exciting career in Regulatory Affairs? Join Ipca Laboratories Limited, a global pharmaceutical leader, as a Regulatory Affairs Executive for the USA market. With a strong focus on ANDA filings and regulatory compliance, this role offers an excellent opportunity to contribute to global healthcare solutions. Apply today!
About Ipca Laboratories Limited:
Ipca Laboratories Limited is a leading global pharmaceutical company dedicated to providing innovative healthcare solutions that enhance the quality of life for patients worldwide. With a strong presence in regulated markets such as the United States, Europe, and Australia, Ipca has established itself as a trusted name in the pharmaceutical industry. The company is committed to innovation, compliance, and maintaining the highest quality standards, ensuring that its products meet stringent regulatory guidelines.
Ipca specializes in the development, manufa
cturing, and marketing of a wide range of pharmaceutical formulations and active pharmaceutical ingredients (APIs). With state-of-the-art facilities, robust research capabilities, and a highly skilled workforce, the company continues to drive progress in the pharmaceutical sector.Job Title: Regulatory Affairs Executive
About the job
Position: Executive – Regulatory affairs formulation for the USA market.
Qualification required:
- Educational Background: Candidates must hold a B.Pharm (Bachelor of Pharmacy) or M.Pharm (Master of Pharmacy) degree.
- Experience: At least 4 – 7 years of experience working in regulated pharmaceutical markets such as the USA, Europe, or Australia. Preference will be given to candidates with hands-on experience in Abbreviated New Drug Application (ANDA) submissions for the USA market.
Key Responsibilities:
As a Regulatory Affairs Executive, the selected candidate will be responsible for:
- Preparation of registration dossiers following US FDA regulatory guidelines, ensuring all documentation is accurate, comprehensive, and compliant.
- Development of renewal applications per the regulatory requirements for continued market approval of pharmaceutical products.
- Handling regulatory queries by efficiently responding to inquiries from regulatory authorities and customers, ensuring smooth approval processes.
- Managing safety, quality, and administrative variations in accordance with the latest regulatory guidelines to maintain product compliance and market stability.
Interested candidates can apply for this opportunity by following the link below:
Keywords: Regulatory Affairs Executive, Ipca Laboratories Limited, Pharmaceutical company, USA market, Regulatory guidelines, ANDA, Healthcare Solutions. Regulatory Affairs Executive at Ipca Laboratories, Pharma Apply
