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International Regulatory Affairs Head
PSS GlOBAL
posted 15d ago
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Key skills for the job
Job Description
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:
- Mentor regulatory team of 5, conduct training sessions on the latest regulatory updates have experience of troubleshooting
- Good communication skills in client handling
- Preparing/ checking and submitting technical files and compilation of dossiers in CTD format as required for semi-regulated countries/markets
- 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
- Handling product registration
- Ensuring Effective and Prompt Attention and Handling of Queries from MOH of various Countries
- Review of technical documents for dossier compilation
- Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purposes
- Preparation of Data required for Artwork subsequent checking
- Co-ordination for Bioequivalence Studies and Comparative Dissolution data as per requirement
- Coordinating with the Plants for Technical Inputs
- 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
- Monitor for changes in regulatory strategy at relevant agencies/authorities to identify potential impact to the companys business segments from emerging regulatory issues
- Preparation, gap analysis of submission documents and authoring technical reports for cross-functional teams
- Ensure a high scientific standard and quality for all regulatory documents
- Handle regulatory activities by setting and managing work priorities and time allocation
- Manage proactive and professional delivery of results for the regulatory activities of all the products to support the business goals
- Review of regulatory documents i.e. dossiers, response to deficiencies, and guide team members
- Providing regulatory support for out-licensing projects
Educational Qualifications And Experience:
- BPharma / BSc
- Minimum 10+ years experience in Regulatory Affairs.
- He should be having working Experience in Oncology
Employment Type: Full Time, Permanent
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