Join Aurobindo Pharma: Regulatory Affairs Professionals (US & EU Markets)

Company: Aurobindo Pharma
Job Title: Regulatory Affairs Professional
Location: APLR C-1, Hyderabad, India

About Aurobindo Pharma:
Aurobindo Pharma is a vertically integrated pharmaceutical company with a robust global presence. Dedicated to making quality healthcare accessible worldwide, we excel in developing, manufacturing, and marketing a diverse range of pharmaceutical products. We are a dynamic and innovative organization committed to excellence and the continuous professional growth of our employees.

Job Summary:
We are actively seeking experienced and driven Regulatory Affairs professionals to enhance our team at the APLR C-1 facility in Hyderabad. These critical roles are focused on managing regulatory submissions, achieving approvals, and overseeing CMC (Chemistry, Manufacturing, and Controls) activities for both the challenging US and diverse European pharmaceutical markets. If you possess a strong background in pharmaceutical regulatory affairs and are ready to take on a significant role in a leading global company, we invite you to explore these opportunities.

Key Responsibilities May Include:

• Preparing, reviewing, and submitting comprehensive regulatory dossiers, including ANDA filings for the US market.
• Managing all aspects of regulatory activities for pre- and post-approval stages in designated markets.
• Leading and executing CMC (Lifecycle Management) initiatives, ensuring compliance with evolving regulatory standards.
• Collaborating with cross-functional teams to gather necessary documentation and data for submissions.
• Responding to regulatory agency queries and ensuring timely approvals.

Open Positions & Requirements:

1. Regulatory Affairs – US Market

• Experience: 4.5 – 6 Years in US Regulatory Affairs.
• Key Exposure: ANDA filing, US regulatory submissions, SPD-Topical / Dermatology-related regulatory activities, and a thorough understanding of regulatory documentation and submission requirements.
• Qualification: B.Pharm / M.Pharm, with a preferred specialization in Regulatory Affairs or Pharmaceutics.

2. Regulatory Affairs – EU Market (Pre & Post Approvals / CMC)

• EU-CMC Post Approvals:
  • Experience: 2 – 5 Years in EU-CMC post-approval activities.
  • Focus: Managing post-approval variations and compliance for the European market.
• EU-CMC Lifecycle Management (LCM):
  • Experience: 8 – 12 Years in EU-CMC-LCM roles.
  • Focus: Strategic oversight and execution of CMC and Lifecycle Management initiatives for the European market.
• Qualification (for all EU roles): M.Pharm, with preferred specializations in Regulatory Affairs, Pharmaceutics, Analysis, or Quality Assurance.

Why Join Aurobindo Pharma?
Be part of a company that prioritizes quality and patient well-being, offers excellent growth prospects, and fosters a collaborative and supportive work environment.

How to Apply:
If you are an experienced professional ready to make an impact, please submit your updated resume. Specific application instructions will be provided to eligible candidates to ensure we connect you with the right recruitment contact for your market specialization. We look forward to reviewing your application!