Are you looking to expand your expertise in project management and drive change in an environment that allows you to design novel approaches and solutions? If so, this Project Manager role could be an ideal opportunity to explore.
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The Job holder works with the GRL/ Regional Rep (TG) or C&EP equivalent to ensure that appropriate content for a range of submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Position: Project Lead – Regulatory
Location: Mumbai, Maharashtra/Bangalore, Karnataka, India
- Accountable to GRL/ Regional Rep/ C&EP lead for delivery of submissions or strategy components for an assigned product in development or marketed product; planning own and submission team activities to ensure delivery to agreed timeframes and appropriate content
- Responsible for the implementation of the submission strategy for TG supported markets
- Responsible for the development and implementation of the submission strategy for NCE Global Delivery supported markets
- Ensures quality of both own and submissions teamwork and compliance with regulatory guidelines and processes as they apply to the role.
- Works with staff from other functions, and should be capable of working to senior levels in development functions in the provision of advice, interpretation of relevant guidance, researching topics, and resolving issues.
- May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.
- Maybe part of the Regulatory Matrix Team for the given product and accountable for the leadership of the relevant submission team.
- May be responsible for the maintenance activities associated with an approved product, including product renewals, label harmonization, PBRER submissions, etc
Desired Experience & Skills:
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Global/ EMAP Regulatory submission experience – Knowledge of regulatory agency guidelines and expectations for submissions.
- Excellent organizational skills, attention to detail and commitment to deliver high-quality output, even under pressures sometimes demanded by regulatory deadlines and managing multiple submissions simultaneously
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
- Ability to effectively interact with line and middle management, staff, and external contacts on a functional and strategic level in a matrix environment.
- Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
- Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
- Proven ability to think flexibly in order to meet constantly shifting priorities and timelines.
Qualification: B.Pharma/B.Sc or Equivalent Healthcare Degree, with Regulatory Exposure
This is a job description to aide in the job posting but does not include all job evaluation details.
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