Job Opportunity: Experienced Regulatory Affairs Professionals (US & EU Markets)
Aurobindo Pharma Limited is a leading global pharmaceutical company committed to delivering affordable and innovative medicines to patients worldwide. We are expanding our dynamic Regulatory Affairs team and are actively seeking highly experienced and dedicated professionals to support our product portfolios for both the US and European markets. If you possess a strong background in pharmaceutical regulatory affairs and are looking for a challenging role in a growth-oriented environment, we encourage you to apply.
About the Role:
As a Regulatory Affairs professional, you will be instrumental in ensuring the compliance of our pharmaceutical products with the regulatory requirements of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). You will be responsible for the preparation, submission, and lifecycle management of regulatory dossiers, playing a critical role in bringing our vital medicines to market and maintaining their approval status.
Key Responsibilities:
- Prepare, review, and compile regulatory submissions, including ANDAs (Abbreviated New Drug Applications) and MAAs (Marketing Authorisation Applications).
- Manage post-approval changes and variations for existing products in the US and EU markets.
- Oversee the Chemistry, Manufacturing, and Controls (CMC) sections of regulatory dossiers.
- Engage in strategic regulatory planning and provide guidance on regulatory requirements and pathways.
- Interact with health authorities and respond to regulatory queries and deficiencies.
- Stay updated with evolving regulatory guidelines and ensure internal compliance.
- Contribute to the overall lifecycle management of pharmaceutical products.
Work Location: APLRC – 1, Hyderabad
Qualifications & Experience:
For US Market Roles:
- Education: B.Pharm or M.Pharm with a specialization in Regulatory Affairs or Pharmaceutics.
- Experience Levels:
- Officer/Executive: 2-5 years of relevant experience in US Regulatory Affairs (Submission/Post-approval, CMC).
- Senior Executive/Assistant Manager: 5-8 years of experience in US Regulatory Affairs (Submission/Post-approval, CMC).
- Deputy Manager/Manager: 8-12 years of experience in US Regulatory Affairs (Submission/Post-approval, CMC).
- Senior Manager/Deputy General Manager: 12-18 years of experience in US Regulatory Affairs (Submission/Post-approval, CMC).
For EU Market Roles:
- Education: M.Pharm with a specialization in Regulatory Affairs, Pharmaceutics/Analysis, or Quality Assurance.
- Experience Levels:
- Officer/Executive: 2-5 years of relevant experience in EU Regulatory Affairs (Submission/Post-approval, CMC/Lifecycle Management).
- Senior Executive/Assistant Manager: 5-8 years of experience in EU Regulatory Affairs (Submission/Post-approval, CMC/Lifecycle Management).
- Deputy Manager/Manager: 8-12 years of experience in EU Regulatory Affairs (Submission/Post-approval, CMC/Lifecycle Management).
- Senior Manager/Deputy General Manager: 12-18 years of experience in EU Regulatory Affairs (Submission/Post-approval, CMC/Lifecycle Management).
How to Apply:
If you are a highly motivated regulatory professional seeking to advance your career with a reputable pharmaceutical leader, we invite you to send your detailed resume to the respective HR email addresses:
- Sreeja.Yangam@aurobindo.com
- Pooja.Uppalapati@aurobindo.com
Join Aurobindo Pharma Limited and contribute to making a difference in global healthcare!
