Product Manager

4 days ago

Mumbai, Maharashtra, India beBeePharmaceuticalManager Full time US$ 60,000 - US$ 1,20,000
Job Title

A Pharmaceutical Manager is required to lead and manage projects, teams, and external partners. This role involves coordinating with various departments such as Ops BD, Tech Ops, Legal, Marketing, Finance, Medical/Pharmacovigilance, Quality, and External Partners like TPMS, Vendors, and FDA, DCGI, Customs.

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  • This includes preparation of project plans and execution, managing global NPI processes, supporting site and product screening for QA and Regulatory compliance, organizing and arranging transfer prices for products and QA audits, following up on CAPAs, and keeping tech ops and SCM teams informed on product and site status.
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  • Also involved in coordinating with TPMs for product manufacturing licenses, arranging product licenses and completing technical dossiers for QA/Regulatory/Medical, following up with cross-functional teams for gap analysis and arranging product dossier compliance from TPMs, getting site and product approval certifications, and closing product supply agreements and quality agreements.
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  • This role also requires supporting and monitoring artwork design and development activities, coordinating with Legal Marketing for brand names, Regulatory for Rule 96 and D C act compliance, Medical for rationale PIL designs, and Quality for overall labeling compliance as per AIL branding guidelines.
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  • Based on sales and physician sample projections, deciding adequate batch sizes with Ops BD and TPM, closing raw material and packaging material specifications and finished good specifications in consultation with Quality/Regulatory/Tech Ops and Ops BD, and coordinating SAP code creation and following up on purchase orders.
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  • Responsible for first three months' supplies of NPI for 2 years.
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    • Individual contributor roles require multiple cross-functional alignments and working.
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    • TPM/CFT for product compliance.
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    • Financial responsibilities include no financial authority, internal and external coordination, internal interactions with Marketing, Legal, Finance, Medical/Pharmacovigilance, Quality, Ops BD/Tech Ops, Packaging Development, and External interactions with TPMS, Vendors, and FDA, DCGI, Customs.
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    • Functional knowledge, managerial expertise, negotiation skills, networking and relationship building, problem-solving and decision-making, communication and interpersonal skills, and digital expertise are essential for this role.
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    • Qualifications include a Master's degree in Pharmacy from a reputable institute and/or an MBA preferably with a science background.
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    • 8-10 years of relevant experience in overall pharmaceutical formulation operations.

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