Job highlights

- In-depth knowledge of regulatory requirements and Health Agency expectations, experience in CMC dossier authoring and review

- Author and review CMC dossier sections, ensure regulatory compliance, coordinate cross-functional data collection, manage team to meet submission targets, and train staff

Role & responsibilities

- Authoring / writing and review of CMC sections of dossier
- Critical review of design stage documents (specifications, controls and protocols) to ensure that regulatory requirements are fulfilled
- Co-ordination for collection of post-execution data from various functions and review for compliance against the design specifications, controls and protocols.




- Collaboration with various cross functional team members for timely conclusion of action items identified for responding deficiencies.
- Review and to check the accuracy of information in various status and database maintained at department / company level
- Ensure compliance of regulatory submissions with current regulations and guidance
- In depth understanding of regulatory requirements and Health Agencys expectations
- Contributes individually or manage the team / subordinates effectively to ensure that target submissions are achieved in time
- Train and develop individuals to achieve department and company goals

📌 Pharmaceutical & Biotechnology - Other (Hyderabad)
🏢 Naukri e-Hire
📍 Hyderabad