Eugia Pharma Specialities Ltd, headquartered in Hyderabad, Telangana, is a well-established pharmaceutical company known for its robust portfolio of pharmaceutical products and commitment to quality. The company focuses on delivering high-standard products across various markets, and it emphasizes innovation and adherence to regulatory norms.
Job Overview
The Regulatory Affairs Specialist position at Eugia Pharma involves handling regulatory submissions, documentation, and strategic planning. With a specific focus on Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA), this role requires strong regulatory expertise and a detailed understanding of compliance in pharmaceutical filings.
Key Responsibilities
- Regulatory Submissions: Plan, review, and submit ANDA and NDA projects.
- Response to FDA Deficiencies: Draft high-quality, compliant responses to FDA queries.
- Post-Approval Changes: Evaluate and interpret post-approval changes for ongoing compliance.
- Supplement Submissions: Prepare and submit CBE (Changes Being Effected), CBE-30, PAS (Prior Approval Supplement), and annual reports.
- Change Control Management: Review and authorize regulatory change controls.
- eCTD Proficiency: Work with electronic Common Technical Document (eCTD), focusing on Modules 2 and 3.
- Regulatory Strategy: Develop US regulatory filing strategies for new projects.
Required Qualifications and Skills
- Educational Background: M.Pharm (Master of Pharmacy).
- Experience: 3 to 8 years in regulatory affairs within the pharmaceutical industry.
- Technical Skills:
- Proficiency in eCTD and understanding of Modules 2 and 3.
- Experience with ANDA and NDA processes.
- Ability to manage supplement submissions such as CBE, CBE-30, PAS, and annual reports.
- Knowledge of FDA regulatory standards and requirements.
- Soft Skills:
- Excellent drafting and communication skills for regulatory documents.
- Strong problem-solving abilities and attention to detail.
- Strategic thinking for developing regulatory filing plans.
