SA Technologies is one of the leading premier IT Consulting Companies in Santa Clara. SAT is an Oracle Gold Partner & Microsoft Partner. We have built highly scalable, world-class consulting processes that offer tremendous business advantages to our clients in the form of huge cost-benefits, definitive results and consistent project deliveries.
Post: Regulatory Affairs Manager
No. of Post: 01
Job Description:
Responsibility includes mainly for India and for Nepal & Bhutan; Submissions include all dossiers for submission to authorities including New Drug /Device applications, Manufacturing site registrations/ import license applications, Clinical Trial applications, Renewal/ Re-registration applications, Query responses, Safety / PSUR submission dossiers, etc.
• Contributing/supporting the head of department in planning and finalizing the local regulatory plan/strategy for the affiliate and executing as per the plan.
• Collection/ procurement/ creation of all required documents well in advance as per submission plan/ timelines
• Compilation/ review/ QC/ dispatch of all the health authority submission dossiers and ensure timely submission to relevant authorities.
• Managing all regulatory activities related to conduct of clinical trials (E.g. NOC, Import and Export license)
• Managing regulatory safety reporting (both solicited and unsolicited safety reporting) as per the Indian regulatory requirements
• Review & approval of all promotional materials from regulatory perspective
• Maintenance of product licenses i.e. renewal /re-registration and import license for all licensed products (India, Nepal and Bhutan)
• Handling ‘Product variations’: Reviewing & providing input to global stakeholders, plan-ning the submissions to local authorities according to their merit and ensure the same is completed as per local & global requirements/ regulations.
• Coordinates well with business area and global teams for procurement of all requirement documents in timely manner.
• Product testing: Coordinates with headquarters for procuring product samples/ other ma-terials required for testing and liaise with relevant drug testing laboratories for completion of activities.
• Updating the global regulatory information system on ongoing basis
• Manage / mentor new joiners and judicious use of department budget.
• Regulatory Intelligence: Keep up to date with current regulatory & quality requirements /regulations and competitor information.
• Record Management of regulatory submission documentations, local archival system /processes, update to the databases/share-point sites as appropriate.
Key Skills:
1. Have in-depth knowledge of local regulations pertaining to product registration requirements for pharmaceutical and medical devices
2. Sound knowledge in regulations regarding ‘conduct of clinical trials’ in India
3. Knowledge of Good Manufacturing Practices, Good Clinical Practices, Good Distribution Practices & Quality Assurance & Pharmacovigilance requirements
Experience: 5-10 yrs
Location: Bengaluru/Bangalore
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