Unichem Laboratories Hiring Regulatory Affairs Executives

Regulatory Affairs Executive Jobs in Mumbai | B.Pharm & M.Pharm Graduates Wanted

Apply for Regulatory Affairs Executive/Sr. Executive role at Unichem Laboratories, Mumbai. B.Pharm/M.Pharm graduates with 5–11 years’ experience required.

Regulatory Affairs Executive Openings in Mumbai for B.Pharm & M.Pharm Professionals

Looking to accelerate your pharmaceutical career in Regulatory Affairs? Unichem Laboratories Ltd. is hiring Executives and Sr. Executives for its Regulatory Affairs (US Market) department in Mumbai. This is a full-time, on-site opportunity for qualified B.Pharm or M.Pharm professionals with 5–11 years of relevant experience.

About Unichem Laboratories

Unichem Laboratories Ltd. is a trusted name in the pharmaceutical industry, known for delivering quality formulations across the globe. With decades of excellence in manufacturing and compliance, Unichem offers a dynamic work environment that encourages innovation and professional development.

Job Highlights

Position

• Regulatory Affairs – US Market
• Executive / Sr. Executive

Location

• Mumbai, Maharashtra (On-site)

Employment Type

• Full-time

Required Experience

• 5 to 11 years

Educational Qualification

• B.Pharm / M.Pharm

Key Responsibilities

• Prepare and author high-quality CMC documentation for US FDA submissions including Original ANDAs, Deficiency Responses, PAS, and Annual Reports.
• Coordinate and obtain technical source documents needed for timely regulatory submissions.
• Review source documents for content and technical accuracy.
• Stay current with regulatory guidelines and global submission requirements.
• Work closely with cross-functional teams and stakeholders to support regulatory deliverables.
• Contribute to overall regulatory strategy and identify lessons learned for future submissions.

Required Skills & Knowledge

Technical Skills

• Strong understanding of CTD/eCTD formats and submission requirements.
• Hands-on experience with eCTD software and e-publishing tools.
• Familiarity with US FDA regulatory documentation and expectations.

Soft Skills

• Strong analytical and review capabilities.
• Proactive attitude with a learning mindset.
• Effective collaboration and communication skills.
• Problem-solving mindset and adaptability.

Why Join Unichem?

• Work with a legacy pharma company known for its global regulatory compliance.
• Be part of a regulatory team that deals directly with international submissions.
• Gain exposure to cutting-edge pharmaceutical development.

Call to Action

👉 Interested and qualified candidates can apply directly via Unichem’s LinkedIn job post.

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