CIPLA Career Opportunities: Team Member - Regulatory Respiratory Master’s degree in Pharmacy Apply Now
Job Purpose
Prepare, review, ,modify, collate, submit documents for
product registrations and maintain life cycle of respiratory products, update
regulatory database, support launches and ongoing commercials to meet the
objectives of regulatory affairs sub-function
Accountabilities
I. Check region-wise regulatory requirements, perform gap
analysis for registered dossiers, compile/recommend regulatory strategy for
product submission to check leveragability, and to support development
activities
II. Compile respiratory product dossiers by collating and
reviewing relevant registration information, submit dossiers as applicable,
compile deficiency responses to facilitate timely approvals of respiratory
products globally
III. Support on-time launches and ongoing commercials of
respiratory products and devices identified by the business plan through cross
functional co-ordination and review of documents to ensure launch within
timeline
IV. Update and provide the regulatory status of respiratory
products for maintenance of the global registration database
V. Manage post-approval life cycle management by contributing
to the closure of change controls, by compiling and submitting regulatory
packages, relevant to life cycle management to
VI. Support portfolio initiatives eg. identifying leverage
products by evaluation of data, compliance with respect to site transfer
initiatives to
VII. Participating in Control Tower, SAP, CIPDOX, GOOSE,
meetings on behalf of respiratory team
Education Qualification
Master’s degree in Pharmacy
Relevant Work Experience
4-5 years of experience in regulatory filing (compilation,
submission and approval) with knowledge of drug product development and
respiratory products (for US/EU/International markets)
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