Requirement: Project Manager
Job CODE: HC/JC/1281/12
Job Category: R & D
Location: Bangalore
Experience: 5-10-years
Education: B.E, B.Pharm, B.Sc, B.Tech, BPHARM, BPHARMA, BSC(HONS), M.B.A, M.Pharm, M.Sc, M.Tech, MPHARM, MPHARMA, MSC TECH, PGDBA, PGDBM, PGDM
Skills:
Good exposure on Pharma Projects (especially Formulation dosage products for regulated markets) with prior exposure to Intellectual Property Management
Industry Type: Pharma/Biotech/Clinical Research
Reporting to the AVP (R&D, Formulation) you will be individually responsible for:
- Managing all project activities relating to internal as well as external (out-licensed) development; from project selection to dossier submission for generic finished dosage products (FDP).
- Coordinating meetings with internal as well as external stakeholders and circulating minutes of meeting promptly.
- Coordinating activities with contract third party vendors, manufacturers, clinical research organizations (CRO) and other related functions.
- Working closely with R&D development team to provide end-to-end solution & project support from early formulation development, method development, pre-exhibit batch, exhibit batch, clinical batch, bio-study & regulatory submission activities.
- Regularly following-up with internal & external stake holders for predefined activities ensuring the project goals are met & deliverables are delivered in time.
- Working closely with commercial, operation and business development teams to provide end-to-end solution & project support from regulatory labelling, process validation, scale up, technology transfer and other related activities.
- Serving as primary support function to other project managers in advancing the development activities including PMs from CRO, CMO, third party vendors etc.
- Coordinating activities to support procurement of all finished dosage components, active & inactive ingredients, and labelling, packaging & other related components.
- Supporting regulatory affairs in filing of all dossiers for submissions & supplement / deficiency activities for regulated markets.
- Providing regular updates to senior management team as well as updating monthly reporting or other tracking database.
- With a Graduate degree in Science/Technology and an MBA in project management from a Tier I institute, you have 5 to 10 years of relevant experience, specifically for pharmaceutical development in the regulated markets. You have prior experience managing different dosage forms and have handled formulation dosage products. You have displayed high levels of persistance and have a go-getter attitude with the ability to function exceptionally well in a high-pressure environment
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