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Designation: General Manager/ Dy General Manager of Regulatory Affairs
Purpose of Job:
- The purpose of this role is to be the lead for the TAPS team within GRA-India Strategy providing strategic guidance to assigned projects through the team lead(s) and/or regulatory strategists reporting to him/her.
- Modeling strong leadership and project management techniques to provide leadership to the TAPS team assuring a global focus of goals, strategies, and plans.
- As a leader, he/she is directly accountable for ensuring regulatory deliverables of the assigned products in accordance with time, cost, and quality expectations for all projects in the portfolio through collaborative working relationships with cluster leads, GRLs, and other stakeholders. Also responsible for staff and talent development, performance management, and as a member of India RA Leadership Team / extended Global Brands Regulatory leadership team, contribute to overall management, alignment, and process improvement and drive the appropriate culture and behaviors through the organization.
The major duties and responsibilities are as below:
- Provides regulatory expertise and leadership within the TAPS team as the senior global regulatory representative responsible for regulatory decisions at the strategic, technical level for the assigned projects across all the TAs within HBU
- Responsible for developing and maintaining an in-depth regulatory knowledge of the portfolio’s within HBU including current and emerging guidelines and regulations (Quality, Safety, and Efficacy), relevant regulatory approaches and actions, and ensuring that knowledge is shared across the team(s) to enable efficient and effective achievement of the assigned project and goals
- Ensures all regulatory contributions (strategies, labeling, submissions, approvals, post-marketing lifecycle management activities, etc.) for the assigned projects achieve the objectives agreed with the cluster leads/GRLs, stakeholders, and partner lines in accordance with time, cost, and quality expectations
- Develops strong and positive working relationships with all the stakeholders including TA leaders.
- Supports TAs in, appropriate activities to influence the regulatory environment.
- Responsible for aggregate resource forecasting for the assigned projects/products across TAs and works in collaboration and cooperation with Portfolio Leads to ensure that adequate resources are assigned to assigned projects.
- Mentors develop and coach Lead (s)/ Regulatory Strategists of the TAPS team for projects within the relevant portfolio(s) including all aspects of the performance management process as appropriate.
- Provides guidance to all regulatory professionals with the area of responsibility to prepare for stakeholder interactions and external and internal project/product presentations
- Works with other regulatory staff to ensure the application of consistent processes and policies across GRA HBU. Directly responsible for ensuring the implementation of these processes and policies.
- Supports the leadership team and drives the required culture and behaviors through the organization
- Champions flexible approaches to ensure efficient and effective resource utilization.
- Ensures learning embedded in the organization.
- Ensures the team maintains compliance in accordance with all appropriate standards.
- Proven experience in managing global and/or regional regulatory process and registration aspects of the drug development process and post-marketing lifecycle management in the Pharmaceutical Industry, preferably in Regulatory Affairs/Health Authority and/or a proven track record of success in negotiating with Health Authorities and in representing interests to internal and external stakeholders.
- Experience managing multiple products simultaneously within or across therapeutic areas and different stages of the product lifecycle is highly desirable.
- Proven ability to manage complex regulatory issues and business processes
- Proven ability to manage a team of regulatory professionals.
- Proven ability to consistently deliver to time, cost, and quality standards
- Proven ability to partner successfully with global stakeholders to achieve objectives
- Knowledge of assigned therapeutic areas/disease areas
- In-depth and relevant Global regulatory experience (more than one region)
- Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
- Proven ability to function autonomously at a senior level in a highly matrixed organization
- Proven ability in developing and implementing regulatory strategy: Demonstrated knowledge of global regulatory procedures and requirements. Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs/CTAs and NDAs /MAA/IRDs.
- Problem Solving and Analysis: Strong problem identification and solving skills, e.g. risk management planning. Strong logical and analytical skills.
- Communication skills: Ability to communicate complex information and analyses to a variety of
- scientific audiences in both verbal and written format, including senior management.
- Negotiation skills: Can negotiate skillfully in tough situations with both internal and external groups. It can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations
Qualification: M.Pharma/M.Sc/Ph.D. in Pharmaceutical Sciences
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