Walk-in | Regulatory Affairs

VIATRIS; Hyderabad; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

VIATRIS in Hyderabad, India is seeking a Regulatory affairs professional to author and review CMC sections of dossiers, ensuring regulatory alignment and timely submissions. The role requires strong attention to detail and the ability to coordinate across multiple functions.

The candidate will lead data collection for post-execution activities, review for compliance with design specifications and regulatory guidance, and mentor junior staff to achieve department goals.

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

Job description

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