Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Manager - Regulatory Affairs
To ensure product (Drug / Device) registration with the Drug Regulatory Agencies and maintenance of the ‘license to operate’. 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 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, planning 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 materials 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.
• Regulatory compliance: responsible to ensure compliance with all applicable regulations and local and corporate requirements.
• Takes up any other relevant projects/ activities as directed by line manager /head of department.
• Safety reporting as per the company procedure
Pharmacy graduate / licensed pharmacist, life science, biomedical or medical graduate. Desirable: Masters in Pharmacy, life sciences, biomedical or medical English Minimum: 5 years’ experience in Regulatory Affairs Desirable: 7 to 8 years experience and Specific experience in RA activities of pharmaceuticals in the area of Ophthalmology products.
Experience : 7-8 years
Qualification : B.Pharm, B.Sc, M.Pharm, M.Sc
Location : Delhi
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 30th August, 2019
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