Pharma Manager Regulatory Affairs Job @ Novartis
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Job Id: 274292BR
Position Title Manager – Regulatory Affairs
Eligibility:
Minimum: 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
Job Description
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 documentation, 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
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