Pharma Manager Regulatory Affairs Job @ Novartis

Pharma Manager Regulatory Affairs Job @ Novartis

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Job Id: 274292BR

Position Title Manager – Regulatory Affairs


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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