Regulatory Affairs

VIATRIS; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

VIATRIS in Hyderabad is looking for a regulatory professional to author and review CMC sections of dossiers, ensuring accuracy and compliance with current guidelines.

You will coordinate cross-functional data collection, review design stage documents, and drive timely submissions while mentoring junior staff toward department goals.

Qualifications

• Author CMC sections for dossiers in compliance with regulatory requirements.
• Experience reviewing design stage documents to ensure regulatory compliance.
• Coordinate collection of post-execution data across functions for review.

Responsibilities

• Author and review CMC sections of dossiers.
• Critically review design stage documents to ensure regulatory compliance.
• Coordinate collection of post-execution data and verify against design specs.
• Collaborate with cross-functional teams to close action items.
• Review accuracy of information in status and databases at department level.
• Ensure submissions comply with current regulations and guidance.
• Develop understanding of regulatory expectations and Health Agency requirements.
• Lead individuals to ensure timely target submissions.
• Mentor and train team members to meet goals.

Skills

Regulatory writing

Cross-functional collaboration

Job description

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