Athena Pharmaceutiques S.A.S.

1 Job openings at Athena Pharmaceutiques S.A.S.
Assistant Manager - CMO Operations & Regulatory Coordination mumbai,maharashtra,india 4 - 5 years None Not disclosed On-site Full Time

Job Profile Person with 4-5 years experience pharma background / purchase - CMO - supply chain – regulatory and quality knowledge Third Party activities – commercialized products Managing / execution / follow up of the purchase orders till the shipment Responsible of dashboards for all supplies Co-ordination with 3rd party manufacturers for smooth processing on all activities related to production / supply Co-ordinating with internal cross functional teams: financial / supply / logistics, etc. Manage production of registration samples till their shipments to African authorities CMO activities Find out and be proactive in new potential CMOs and new products Agreements to be initiated and followed up with the legal department Initiate and follow new developments and launches at existing and new CMOs Regulatory and quality aspects Co-ordination with 3rd party manufacturers for smooth processing on all activities related to quality / regulatory Manage QA data as per the requirements & routine follow up for stability / APQR, etc Manage our customers regulatory queries in coordination with Athena RA and 3rd party RA team Review of products dossiers changes Responsible of dashboards for all regulatory documentation updates (licensing / WHO/ COPPs / FSCs) Co-ordination and inputs on artwork initiation and/or changes Manage the 3rd party manufacturers site audits (planification / organization / follow ups / CAPA)