vasitum
Location
Mumbai | India
Job description
The project manager is responsible for ensuring that new products are developed on time within budget and in line with all regulatory requirements. This will be an individual contributor role at an Assistant Manager / Manager level based at Mumbai and will report to the Managing Director / Executive Director.
Role:
To monitor the product development process which involves but not limited to formulation development trials
stability regulatory approvals tech transfer to plant commercial batch production and launch.
Act as the clients point of contact and project owner for coordination across all relevant internal functions
and to ensure product deliveries.
Monitoring the sourcing of APIs Excipients as well as packaging materials as per specifications for European
markets and ensuring the availability of required documentation for the same.
Establishing and maintaining timelines for phases of the project and ensuring proper compliant completion of
each one.
Staying up to date on all applicable regulatory guidelines.
Regular followup for project status update with internal & external stake holders and drive the projects
allocated.
Preparing project plan and driving executions as per plan.
To monitor the budget / spending wrt all procurement and to flag off concerns in advance.
Update the Directors about the overall health of the projects allocated.
MIS update on a monthly basis for the projects allocated.
To prepare and share periodic reports to the stakeholders on the projects.
To successfully manage technical projects other than product development projects as and when deemed fit.
Prerequisites:
Overall experience of approximately 7 years in functions such as Production / Quality Assurance / Research &
Development / Regulator Affairs with at least 3 years in the desired role in the pharmaceutical industry.
Good knowledge of product development / CMO cycles for European markets.
Good understanding of regulatory requirements for obtaining EU GMP approval.
Proven abilities in managing a matrix structure.
Exceptional attention to detail and advanced organizing skills.
Proven ability to independently and proactively drive the Organizational requirements
product development,project management,budgeting,stakeholder management
Job tags
Salary
