Pfizer Pharmacy, Pharmacology Regulatory Affairs Job Opening – Apply Online

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.,

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

#LI-PFE

APPLY ONLINE HERE

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