- Professional
- Bureau à Pune
Job Description
| Drafting the regulatory submission files for domestic, emerging, and regulated markets. |
| Handling queries received from various health authorities. |
| Review of GMP documents as per the regulatory requirements. |
| Preparation of Post approval change (PAC) applications and other regulatory activities. |
| Coordination with the business partners for the marketing authorization applications in various geographies. |
| Understanding of regulatory requirements for biosimilar products is desirable. |
| Handling of online portals for various submissions in India, Emerging markets, and regulated markets. |
| Good oral and written communication are mandatory. |
Work Experience
2 to 4 years of relevant experience in regulated markets
Education
Masters in Biotechnology or Veterinary Science
Post Graduation in Pharmacy or Biopharmaceutics
Competencies
1. Strategic Agility
2. Innovation & Creativity
3. Customer Centricity
4. Developing Talent
5. Result Orientation
6. Process Excellence
7. Collaboration
8. Stakeholder Management
