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Assisstant Manager, Regulatory Affairs


Mumbai, MH 400051
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Job Details

**1. Strategic/Policy:**

+ Delivery on compliance in regulatory processes for all local products marketed for Pfizer India.

**2. Operational:**

**- Regulatory Operations**

+ Provide inputs towards improving operational efficiency and effectiveness of regulatory operations for India and India region markets.

+ Compile dossiers to support new product launches per applicable regulatory rules and procedures.

+ Co-ordinate for the activities related to locally manufacturing product: Manufacturing license application, label text, local product document, and artworks approval.

+ 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 with relevant distributors to obtain regulatory approvals.

+ Coordinate with India-region market distributors for regulatory activities, as required

+ Resolution of regulatory issues with the relevant authorities for clearance of consignment

+ Ensure maintenance of Pearl for India.

+ Responsible for developing regulatory processes and local guidance documents for relevant regulatory operations.

+ Coordinate documents from Pfizer global teams for regulatory submissions and approvals.

+ Responsible for assessment of requirements and submission of RAN.

+ Support Institutional business by providing regulatory documentation as required.

+ Responsible for maintaining effective communication channel with all stakeholders.

+ Responsible for maintaining regulatory requirement database for New Chemical Entities, line- extension, variation and renewals for India.

+ Responsible for updating the Regulatory parameters for monthly reports to local and global customers.

+ Responsible for keeping customers informed about progress/ delay of approvals.

+ Contribute to a culture of continuous improvement within the team by ensuring processes and systems are challenged and improved in order to give best advantage to the business.

+ Ensure revision of LPDs (Local Product Document) aligned to the source country label revision issued through PfLEET within specified time frame.

+ Ensure revision of non- source country based LPDs in co-ordination with product physician.

+ Ensure uploading of new and revised LPDs to local repository/GDMS (Global Document Management System).

+ Ensure maintenance of documentation for activities related to labeling.

+ Ensure notification of labeling changes to local regulators and distribution of revised LPD to relevant stakeholders in accordance with SOPs.

+ To initiate artwork per market requirement for new products taking inputs from all relevant stakeholders and review and approval of artworks per local regulatory requirements.

+ Database compliance - updation in Epalms & locally made archival system.

+ 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.

+ Responsible for obtaining regulatory intelligence at local state level.

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