Job for B.Pharm as Manager in CMC Variations at GlaxoSmithKline Pharmaceuticals Ltd
GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.
Post : Manager CMC Variations
• Manage HR aspects for a team of direct reports including recruitment, training and development
• Manage and take accountability of workload within assigned team and work with other team leads within functional area to address resource challenges
• Build CMC competencies in team and coach the team when needed.
• Responsible for tracking/reporting on team performance against key indicators
• Provide peer review and quality check support as requested and able
• Serve as point of escalation for team members
• Maintain a workload in area of responsibility; provide support to team in problem solving
• Participate in quality or continuous process improvement activities related to area of responsibility or as requested
• Maintain appropriate organizational networks
• Recognizes matters that affect corporate or agency policies and escalates issues with high business
• impact or risk.
• Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products/registration data management/submission format to expedite submission, review and approval of global applications.
• Coach and Advise and assist authors with more complex variations or non-routine assignments
• Along with team management the individual will also deliver individual projects
• Independently and confidently executes agreed assignments strategy
• Independently manages multiple project assignments in the area of responsibility simultaneously; assignments will range in complexity but more complex work is expected
• Independently completes data assessment/data maintenance tasks/complex submission packages to ensure output is fit for purpose.
• Bachelor’s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience (consult manager on equivalent regulatory experience)
• 10 + years of experience in Regulatory Affairs in CMC variations for or related responsibilities for Rx and Vx of which 2+ years managing teams delivering CMC outputs
• Managed a Variation team of more than 5 people that successfully delivered outputs to time and quality over a sustained period
• Worked within a global organization across different geographical locations
• Successfully performed within a regulated or quality-critical environment
• Direct or indirect experience of regulatory processes associated with gaining and maintaining product registrations for both Investigational and Licensed Products
• Successful and sustained delivery of a significant number of variation packages including a broad range of submission types across EU/US and International markets
Experience : 5+ years
Qualification : B.Pharm, B.Sc
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory
End Date : 7th February, 2020
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