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
- 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
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