International Regulatory Affairs Head (PSS06893)

has been mandated to hire an International Regulatory Affairs Head for a leading fastest growing pharma organization.

Job Purpose:

International Regulatory Affairs Head will be responsible for filings and registrations across the exporting countries including ROW, Europe, Canada, Mexico, Asia, Africa, LATAM, CIS, Brazil.

Key Responsibilities:

1. Mentor regulatory team of 5, conduct training sessions on the latest regulatory updates have experience of troubleshooting
2. Good communication skills in client handling
3. Preparing/ checking and submitting technical files and compilation of dossiers in CTD format as required for semi-regulated countries/markets
4. Product life-cycle management in ROW & EU (Argentina, Australia, Brazil, Canada, India, Mexico, Russia, South Africa, Switzerland, Turkey, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Belgium and Bulgaria) markets
5. Handling product registration
6. Ensuring Effective and Prompt Attention and Handling of Queries from MOH of various Countries
7. Review of technical documents for dossier compilation
8. Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purposes
9. Preparation of Data required for Artwork subsequent checking
10. Co-ordination for Bioequivalence Studies and Comparative Dissolution data as per requirement
11. Coordinating with the Plants for Technical Inputs
12. Preparation and checking of legal documents like applications to FDA for product permission, FSC, COPP, Health Certificates, DCGI permissions for formulations, neutral code, labeling, etc
13. Monitor for changes in regulatory strategy at relevant agencies/authorities to identify potential impact to the companys business segments from emerging regulatory issues
14. Preparation, gap analysis of submission documents and authoring technical reports for cross-functional teams
15. Ensure a high scientific standard and quality for all regulatory documents
16. Handle regulatory activities by setting and managing work priorities and time allocation
17. Manage proactive and professional delivery of results for the regulatory activities of all the products to support the business goals
18. Review of regulatory documents i.e. dossiers, response to deficiencies, and guide team members
19. Providing regulatory support for out-licensing projects

Educational Qualifications And Experience:

1. BPharma / BSc
2. Minimum 10+ years experience in Regulatory Affairs.
3. He should be having working Experience in Oncology