Pharmaceutical & Biotechnology - Other

Naukri E-hire; Hyderabad; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Naukri E-hire is seeking an experienced regulatory professional to author and review CMC sections of dossiers, ensuring compliance with regulatory requirements and Health Agency expectations. You will coordinate cross-functional data collection and guide the team to meet submission targets.

Responsibilities include critical review of design stage documents, coordinating post-execution data, addressing deficiencies, and training staff to achieve department goals with timely submissions.

Qualifications

• Authoring and reviewing CMC sections of dossiers
• Regulatory compliance and Health Agency expectations
• Cross-functional data coordination and team management

Responsibilities

• Authoring / writing and review of CMC sections of dossier
• Critical review of design stage documents to ensure regulatory requirements are fulfilled
• Coordination for collection of post-execution data and review for compliance
• Collaboration with cross-functional teams to close actions for deficiencies
• Review and ensure accuracy of information in department databases
• Ensure submissions comply with current regulations and guidance
• In-depth understanding of regulatory requirements and Health Agency expectations
• Contribute individually or manage the team to meet submission targets
• Train and develop individuals to achieve department goals

Job description

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

• 1. Authoring / writing and review of CMC sections of dossier
• 2. Critical review of design stage documents (specifications, controls and protocols) to ensure that regulatory requirements are fulfilled
• 3. Co-ordination for collection of post-execution data from various functions and review for compliance against the design specifications, controls and protocols.
• 4. Collaboration with various cross functional team members for timely conclusion of action items identified for responding deficiencies.
• 5. Review and to check the accuracy of information in various status and database maintained at department / company level
• 6. Ensure compliance of regulatory submissions with current regulations and guidance
• 7. In depth understanding of regulatory requirements and Health Agencys expectations
• 8. Contributes individually or manage the team / subordinates effectively to ensure that target submissions are achieved in time
• 9. Train and develop individuals to achieve department and company goals