Avantor Regulatory Assistant Manager Vacancy - Chemistry & Pharmacology

Avantor Regulatory Assistant Manager Vacancy – Chemistry

Avantor hiring chemistry and pharmacology candidates with a masters degree.  Assistant Manager-Regulatory job opening 2021, Pharma job opening 2021, Chemistry job vacancy 2021. Check out all the details on the same below:

Job Title: Assistant Manager-Regulatory

Location: Gurgaon, IND


  • Bachelor/Master’s degree in chemistry, pharmacology,
  • 6 -8 years experience in regulatory affairs in Indian jurisdiction
  • Comprehensive understanding of legal requirements
  • Experience in Pharma / Lab Supply Chemicals or equivalent experience

Job Summary

  • Will be responsible for all day-to-day regulatory affairs for Biopharma, India.
  • Support the business to resolve daily regulatory queries and ability to advise and provide recommendations on regulatory matters
  • Develop team spirit and teamwork.
  • Identify problems and update working methods in own role with the benefit of defined procedures.
  • Escalation of issues to the RA leadership
  • Review and submit registration applications in a timely manner and follow up through the application during the evaluation phase to achieve a favorable outcome.
  • NOC applications for dual-use Biopharma products
  • Review and development of artworks & labeling as per requirements of Drugs & Cosmetic Act and Rules/ Legal Metrology Act.
  • To support the business for new BIS registrations for Biopharma in India for timely registration and on-time approvals. Prepare the product registration as per BIS guidelines and other regulatory dossiers as per the requirement.
  • Liaison with Regulatory Agencies in India (BIS, CDSCO & Local FDA) and provide them required regulatory documents during submission and approval process.
  • Knowledge about Indian Regulatory Guidelines, chemicals, excipients and update the management regarding the local Legislation, Handbook, and Legal Compliance Vigilance.
  • Imparting training to internal and external stakeholders viz. Biopharma customers
  • Regulatory Intelligence & Compliance Discussions and Query replies as per stipulated due dates to avoid delays to the Authority
  • Supporting Indian Biopharma customers with the appropriate information as per NMPA guidelines required for filing of a dossier in China market.
  • Prepare and review the regulatory documents required by customers for qualification of Avantor’s Biopharma products.
  • Regulatory Support during the Audits (internal/external)
  • Set up and maintain procedures and local RA compliance process where relevant:
  • Local license management
  • Reporting to authorities
  • Quarterly RA Sign-Off reviews & follow-up
  • Monthly inspection reporting
  • Local handbook & vigilance file
  • Support the business to resolve daily regulatory queries
  • Install KPIs/Dashboards as required

Apply Online

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