Pfizer
Location
Mumbai | India
Job description
The PCO based colleague Assistant Manager responsible for the regulatory activities both (Operational & Strategy) for assigned Portfolio (Local & Imported) for Pfizer India.
Strategic/Policy:
Delivery on compliance in regulatory processes for all assigned products marketed for Pfizer India.
Operational:
Regulatory Operations
Co-ordinate for the activities related to assigned portfolio like new drug applications , Form 41 & Form 45 applications, manufacturing license applications, label text updates and artworks approval.
Co-ordinate for the activities related to TP: Manufacturing license application, label text, local product documents, and artworks approvals.
Procure Test License for testing of new product development / line extensions (SKUs ).
Co-ordinate with the relevant customers (internal / external) for trigger / support to regulatory issues arising out of PGS product manufacturing.
Co-ordinate with the regulatory liaisoning group to follow up for obtaining /renewal /cancellation of manufacturing licenses and additional product permissions.
Maintain the systems and processes related to PGS regulatory business.
Compile documents for renewals, variations, line-extension and maintenance of licenses.
Ensure maintenance of product and license information in the tracking database.
Coordinate/perform activities related to regulatory submissions and do follow up to obtain regulatory approvals.
Coordinate documents from GCMC Hubs for regulatory submissions and approvals.
Responsible for RAN management (review, response, submission and approval).
Ensure revision of LPDs (Local Product Document) aligned to the source country label revision issued through PfLEET within specified time frame.
Ensure notification of labeling changes to local regulators and distribution of revised LPD to relevant stakeholders in accordance with SOPs.
Responsible for maintaining effective communication channel with all stakeholders.
Ensure maintenance and update of the regulatory databases i. e. (PEARL, GDMS, Epalms-II & PfLEET2) and other pertinent details related to PGS and India region (local & imported) products.
Monitor compliance and implement corrective actions for ensuring delivery on regulatory benchmarks.
Generate and meet customer expectations on regulatory support and deliverables.
Contribute to Pfizer s quality-consciousness and research-based image.
Demonstrate and promote Pfizer global value system across all interactions.
Implement technology solutions for enabling better information availability.
QUALIFICATIONS / SKILLS
A graduate or post-graduate degree in Pharmacy, Pharmaceutical Medicine, Pharmacology, or any other pharmaceutical regulatory discipline.
Scientific Degree. A higher degree (MS or Ph. D) may be an advantage but is not essential.
Pharmacist degree may be mandatory in some countries.
Appropriate regulatory experience in industry minimum 5 - 10 years experience
Management Degree (Undergraduate or MBA) may be an advantage.
Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
General management experience and previous line management and leadership experience at senior management level is essential
Proven ability to manage complex regulatory issues.
Proven ability to consistently deliver to time, cost and quality standards.
Demonstrable experience of effective delivery in a complex matrix environment
Internal Interaction: Commercial, Medical, Above Country Colleagues, RRL, HSM, HLM, GRRS team etc. ,
External Interaction: Government Health Authority, BoH, etc. ,
Regulatory Affairs #LI-PFEJob tags
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