Pfizer Looking For Assistant Manager, Regulatory Affairs at Mumbai, Maharashtra, Full Time

The PCO based colleague Assistant Manager is mainly responsible for end-to-end regulatory activities i.e. both (Operational and Strategy) for India & India Region cluster markets including Clinical Trial Applications of both local and imported products. He/she would work to ensure collaborative connectivity with the key stakeholders (e.g. Commercial, Medical & Above Country Colleagues etc.) and product life-cycle management in compliance with local regulations and Company Standard Operating Procedures (SOPs) for Pfizer India.

Responsibilities:

Strategic/Policy:

• Delivery on compliance in regulatory processes for assigned Therapy area both for local and imported products marketed for Pfizer India/ India region.
• Operational:
• Regulatory Operations
• Co-ordinate for the activities related to assigned Therapy area & new drug applications, Form 41 & Form 45 applications, manufacturing license applications, label text updates and artworks approvals.
• Procure Test License for testing of new product development / line extensions (SKUs) etc.,
• 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. (RPS, 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:

4 – 6 years’ of relevant experience in Regulatory in Pharma industry

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.
• 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

ORGANIZATIONAL RELATIONSHIPS:

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.

Internal Interaction: Commercial, Medical, RRL, HSM, HLM, GRRS team etc.,

External Interaction: Government Health Authority, BoH, etc.,

This is a 5 day working office based role.

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

Regulatory Affairs