Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Global Program Regulatory Director
Job Description
The Global Program Regulatory Director (GPRD) is a Regulatory Affairs leader, supporting Global Program Team(s) (GPTs). Functions independently with minimal supervision as a core member of the GPT to define and implement the global regulatory strategy for the development, submission, approval and life cycle management of the project(s) in close collaboration with the Global Therapeutic Area Lead (GTAL), as appropriate. Responsible for leading a high functioning global regulatory subteam(s) for the program. May also have full regulatory responsibility for one or more early projects with little or no RA sub-team support as appropriate. People Manager: Responsible for leading a high functioning team (GPRM-LCMs and Coordinators-LCM) within the assigned TA (1st line manager operational/company manager): performance, development plan, coaching, training, collaboration with other LCM Team Leads (resource & activities planning, knowledge exchange).
The Global Program Regulatory Director (GPRD) is a Regulatory Affairs leader, supporting Global Program Team(s) (GPTs). Functions independently with minimal supervision as a core member of the GPT to define and implement the global regulatory strategy for the development, submission, approval and life cycle management of the project(s) in close collaboration with the Global Therapeutic Area Lead (GTAL), as appropriate. Responsible for leading a high functioning global regulatory subteam(s) for the program. May also have full regulatory responsibility for one or more early projects with little or no RA sub-team support as appropriate. People Manager: Responsible for leading a high functioning team (GPRM-LCMs and Coordinators-LCM) within the assigned TA (1st line manager operational/company manager): performance, development plan, coaching, training, collaboration with other LCM Team Leads (resource & activities planning, knowledge exchange).
Regulatory Strategy
1. Provide regulatory leadership to assigned project(s).
2. Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.
3. Ensure that Regional/CPO input is sought and incorporated into global regulatory strategy
4. Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks.
5. Responsible for development and implementation of the Regulatory Seed Document/ Regulatory Functional Plan.
6. Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of key program changes/information to support appropriate, timely communication to Health Authorities globally.
7. Partner with regions to align on regulatory strategy in order to fullfill business objectives.
8. Obtain timely consultation with RA line management and Novartis advisory boards on regulatory strategy.
9. Lead interactions with regulatory consultants/advisors for strategic input and challenge.
10. Represent RA on the GPTs and communicates key program information to regulatory team members and RA management.
11. Provide strategic input to GPT and RA team on key HA documents, obtaining appropriate line endorsement as appropriate.
12. Provide strategic input, review and approve clinical study protocols and protocol amendments HA Interactions
1. Develop global regulatory strategy and plans for Health Authority (HA) interactions as appropriate.
2. Contribute to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions. Ensure responses are in line with development strategy.
3. May lead interaction with HAs during key HA meetings
4. Provide leadership by supporting the GPRMs in their direct interactions with HAs as appropriate..
5. May serve as local HA liaison depending on location (e.g., FDA or EMA).
1. Provide regulatory leadership to assigned project(s).
2. Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.
3. Ensure that Regional/CPO input is sought and incorporated into global regulatory strategy
4. Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks.
5. Responsible for development and implementation of the Regulatory Seed Document/ Regulatory Functional Plan.
6. Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of key program changes/information to support appropriate, timely communication to Health Authorities globally.
7. Partner with regions to align on regulatory strategy in order to fullfill business objectives.
8. Obtain timely consultation with RA line management and Novartis advisory boards on regulatory strategy.
9. Lead interactions with regulatory consultants/advisors for strategic input and challenge.
10. Represent RA on the GPTs and communicates key program information to regulatory team members and RA management.
11. Provide strategic input to GPT and RA team on key HA documents, obtaining appropriate line endorsement as appropriate.
12. Provide strategic input, review and approve clinical study protocols and protocol amendments HA Interactions
1. Develop global regulatory strategy and plans for Health Authority (HA) interactions as appropriate.
2. Contribute to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions. Ensure responses are in line with development strategy.
3. May lead interaction with HAs during key HA meetings
4. Provide leadership by supporting the GPRMs in their direct interactions with HAs as appropriate..
5. May serve as local HA liaison depending on location (e.g., FDA or EMA).
Candidate Profile
Min MSc in Life Sciences/ M.Pharm Min 8 years of experience in EU and/or US RA (RA DU, GL) for in-market products, additional regional RA, drug safety, clinical development experience desirable. English
• Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas:
• Innovation in regulatory strategy.
o Prior history with post-marketing/brand optimization strategies and commercial awareness
o Major involvement in a CTD/MAA/NDA submission and approval.
o Leadership role in HA negotiations in multiple regions.
o Proven success in global drug regulatory submissions.
o Proven ability to analyze and interpret efficacy and safety data.
o Regulatory operational expertise.
• Minimum 2-5 years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.
• Global matrix management people management experience desirable.
• Good management, interpersonal, communication, negotiation and problem solving skills.
• Organizational awareness (e.g., interrelationship of departments, business priorities), including experience.
Min MSc in Life Sciences/ M.Pharm Min 8 years of experience in EU and/or US RA (RA DU, GL) for in-market products, additional regional RA, drug safety, clinical development experience desirable. English
• Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas:
• Innovation in regulatory strategy.
o Prior history with post-marketing/brand optimization strategies and commercial awareness
o Major involvement in a CTD/MAA/NDA submission and approval.
o Leadership role in HA negotiations in multiple regions.
o Proven success in global drug regulatory submissions.
o Proven ability to analyze and interpret efficacy and safety data.
o Regulatory operational expertise.
• Minimum 2-5 years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.
• Global matrix management people management experience desirable.
• Good management, interpersonal, communication, negotiation and problem solving skills.
• Organizational awareness (e.g., interrelationship of departments, business priorities), including experience.
Additional Information
Experience : 6-8 years
Qualification : M.Sc, M.Pharm
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory
End Date : 30th January, 2018
Experience : 6-8 years
Qualification : M.Sc, M.Pharm
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory
End Date : 30th January, 2018
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