Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Asst. Manager
Job Description:
- Licence Management for all FDA licenses related to Aurangabad site.
- Co-ordination for data collection & preparation of all types of applications related to plan approvals; manufacturing licenses; additional product permissions; Form 29 Test licenses; NDPS license; Poison license etc. in adherence to National legislation for submission to State FDA.
- Co-ordination for data collection & preparation of all types of applications related to Written Confirmation; WHO.GMP certification in adherence to EU / WHO TRS / National legislation; Certificate of Pharmaceutical Products; Form 29 Test Licenses NOC, Export NOC, Import License for submission to CDSCO.
- Co-ordination with HR on updates regarding Technical staff at Aura location w.r.t new joinees, resignation etc. & updating current status in XLN software. Arranging FDA approvals for Technical staff as per organization requirement.
- Quality submission of applications to FDA as per timelines with close follow ups with Authorities for approvals.
- Life Cycle Management of all approvals granted by Indian FDA for Hospira Aura.
- Maintenance of Regulatory database (Tracker) specific for Licence Management with Regular updates.
- Tracking of changes in Indian FDA Regulations & communication to CFTs within Organization on legislation updates.
- To organise & support State FDA / CDSCO Inspections and execution of respective action plans including follow ups for Inspection report & CAPA.
- Adherence and maintenance of SOPs relevant to License Management.
- Compliance with standards, procedures and policies set forth for the Regulatory function and fully support Hospira, a Pfizer Company, DRA initiatives.
- To archive applications submitted to FDA & maintenance of scanned soft copies in appropriate location.
- Preparation and submission of periodical reports in co-ordination with CFTs w.r.t. NDPS drugs to State FDA & CBN Gwalior.
- To submit information related to Contract Testing Laboratories (Form 37 Labs) utilized by the Site for testing purpose and to update the same to State FDA as and when required.
- To submit updated information related to Board of Directors to the State FDA.
- Any other regulatory activity which may be assigned on need basis.
Candidate Profile
Bachelors or Master in Science / Pharmacy
Minimum 5 to 10 years in Regulatory Affairs with reputed pharmaceutical organization
Additional Information:
Experience: 5 to 10 Years
Location: Aurangabad
Education: M.Pharm, M.Sc, B.Pharm
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Manager
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