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3 Sakar Healthcare Jobs
Asst. Manager/ Manager Regulatory Affairs (Europe)
7-12 years
₹ 6 - 13L/yr
Ahmedabad
1 vacancy
Asst. Manager/ Manager Regulatory Affairs (Europe)
Sakar Healthcare
posted 19d ago
Job Role Insights
Fixed timing
Key skills for the job
Job Description
- Mentor regulatory team of 5, conduct training sessions on the latest regulatory updates have experience of trouble shooting
- Good communication skills 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 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 purpose
- 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 company s 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
Employment Type: Full Time, Permanent
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