Senior Regulatory Programs Manager
2 weeks ago
Job ID: REQ
Location: United Kingdom
SummaryWe are seeking a highly skilled Senior Global Program Regulatory Manager to join our team at Advanced Accelerator Applications (Italy) - S...
About the RoleMajor Accountabilities:
Regulatory Strategy
- Develop and implement the global regulatory strategy for programs through development, registration, and post-approval in the assigned region(s).
- Provide input to global program regulatory strategy, including regulatory designations & innovative approaches.
- Coordinate regulatory readiness with other line functions, Country Organizations & Regions.
Regulatory Submissions
- Lead planning, preparation, and submission of clinical trials, and the implementation of defined global registration strategy into regional submissions worldwide.
- Coordinate, plan, and prepare for submission of initial registrations and post-approval applications.
- Lead regulatory activities during HA reviews, responding to questions and HA interactions.
Regulatory Excellence & Compliance
- Ensure timely RA input and submission of regulatory compliance and maintenance reports.
- May serve as a RA subject matter expert and assume a mentoring role.
Life Cycle Management
- You may also focus on one of the following key areas of activity:
- Maintenance – preparation of selected global regulatory submissions.
- Portfolio Transformation – e.g. streamlining activities, divestment/ integration, portfolio transformation, and manufacturing transfer.
- Business & Operational Excellence – collating, for example, registration samples, CPPs etc. to support submissions.
Your Experience:
- Science-based bachelor's or advanced degree, plus advanced understanding of pharmaceutical development and clinical trials.
- Awareness of post-marketing/brand optimization strategy, with a track record of involvement in regulatory or pharmaceutical development in Phases I – IV, in multiple geographies.
- Strong interpersonal skills and experience working in a complex, cross-functional organization and leading cross-functional teams.
- Compliance and Quality mindset.
- Fluency in English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
-
Senior Regulatory Programs Manager
1 week ago
London, Greater London, United Kingdom SENIOR SPIRIT OF ROSELLE PARK Full timeSenior Global Program Regulatory ManagerAt SENIOR SPIRIT OF ROSELLE PARK, we are seeking a highly skilled Senior Global Program Regulatory Manager to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in developing and implementing the global regulatory strategy for our programs.Key Responsibilities:Develop and...
-
Senior Regulatory Programs Manager
1 month ago
London, Greater London, United Kingdom SENIOR SPIRIT OF ROSELLE PARK Full timeSenior Global Program Regulatory ManagerAt SENIOR SPIRIT OF ROSELLE PARK, we're committed to delivering innovative solutions that improve people's lives. As a Senior Global Program Regulatory Manager, you'll play a critical role in shaping our regulatory strategy and ensuring compliance with global regulations.Key Responsibilities:Develop and implement...
-
Senior Regulatory Programs Manager
1 month ago
London, Greater London, United Kingdom SENIOR SPIRIT OF ROSELLE PARK Full timeSenior Global Program Regulatory ManagerAt SENIOR SPIRIT OF ROSELLE PARK, we're committed to delivering innovative solutions that improve people's lives. As a Senior Global Program Regulatory Manager, you'll play a critical role in shaping our regulatory strategy and ensuring compliance with global regulations.Key Responsibilities:Develop and implement...
-
Senior Regulatory Programs Manager
1 month ago
London, Greater London, United Kingdom SENIOR SPIRIT OF ROSELLE PARK Full timeSenior Global Program Regulatory ManagerAt SENIOR SPIRIT OF ROSELLE PARK, we're committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Key Responsibilities:Develop and implement the global regulatory strategy for programs through development, registration, and post-approval...
-
Senior Regulatory Programs Manager
1 month ago
London, Greater London, United Kingdom SENIOR SPIRIT OF ROSELLE PARK Full timeSenior Global Program Regulatory ManagerAt SENIOR SPIRIT OF ROSELLE PARK, we're committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Key Responsibilities:Develop and implement the global regulatory strategy for programs through development, registration, and post-approval...
-
Senior Regulatory Programs Manager
3 weeks ago
London, Greater London, United Kingdom SENIOR SPIRIT OF ROSELLE PARK Full timeSenior Global Program Regulatory ManagerAt SENIOR SPIRIT OF ROSELLE PARK, we're committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Key Responsibilities:Develop and implement the global regulatory strategy for programs through development, registration, and post-approval...
-
Senior Regulatory Programs Manager
3 weeks ago
London, Greater London, United Kingdom SENIOR SPIRIT OF ROSELLE PARK Full timeSenior Global Program Regulatory ManagerAt SENIOR SPIRIT OF ROSELLE PARK, we're committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Key Responsibilities:Develop and implement the global regulatory strategy for programs through development, registration, and post-approval...
-
Senior Regulatory Programs Manager
1 week ago
London, Greater London, United Kingdom https:magnet.mesitemap Full timeSenior Global Program Regulatory ManagerAt Novartis, we are committed to reimagining medicine to improve and extend people's lives. To achieve this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our...
-
Senior Regulatory Programs Manager
2 weeks ago
London, Greater London, United Kingdom Novartis Farmacéutica Full timeSenior Global Program Regulatory ManagerNovartis is seeking a highly skilled Senior Global Program Regulatory Manager to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in developing and implementing the global regulatory strategy for our programs.Key Responsibilities:Develop and implement global regulatory...
-
Senior Regulatory Programs Manager
2 weeks ago
London, Greater London, United Kingdom Novartis Farmacéutica Full timeSenior Global Program Regulatory ManagerNovartis is seeking a highly skilled Senior Global Program Regulatory Manager to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in developing and implementing the global regulatory strategy for our programs.Key Responsibilities:Develop and implement global regulatory...
-
Senior Regulatory Programs Manager
1 week ago
London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full timeSenior Global Program Regulatory ManagerJob Summary:We are seeking a highly skilled Senior Global Program Regulatory Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing the global regulatory strategy for programs through development, registration, and post-approval in...
-
Senior Regulatory Programs Manager
1 month ago
London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full timeSenior Global Program Regulatory ManagerJob Summary:We are seeking a highly skilled Senior Global Program Regulatory Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing the global regulatory strategy for programs through development, registration, and post-approval in...
-
Senior Regulatory Programs Manager
1 month ago
London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full timeSenior Global Program Regulatory ManagerJob Summary:We are seeking a highly skilled Senior Global Program Regulatory Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing the global regulatory strategy for programs through development, registration, and post-approval in...
-
Senior Regulatory Programs Manager
1 month ago
London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full timeSenior Global Regulatory ManagerOur company is seeking a highly skilled Senior Global Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will play a critical role in developing and implementing the global regulatory strategy for our programs.The successful candidate will have a strong understanding of pharmaceutical...
-
Senior Regulatory Programs Manager
1 month ago
London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full timeSenior Global Regulatory ManagerOur company is seeking a highly skilled Senior Global Regulatory Manager to join our team. As a key member of our regulatory affairs team, you will play a critical role in developing and implementing the global regulatory strategy for our programs.The successful candidate will have a strong understanding of pharmaceutical...
-
Senior Regulatory Programs Manager
2 weeks ago
London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full timeSenior Global Regulatory ManagerOur company is committed to delivering innovative solutions that improve people's lives. To achieve this, we need talented individuals like you to join our team. As a Senior Global Regulatory Manager, you will play a key role in developing and implementing the global regulatory strategy for our programs.The successful...
-
Senior Regulatory Programs Manager
2 weeks ago
London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full timeSenior Global Regulatory ManagerOur company is committed to delivering innovative solutions that improve people's lives. To achieve this, we need talented individuals like you to join our team. As a Senior Global Regulatory Manager, you will play a key role in developing and implementing the global regulatory strategy for our programs.The successful...
-
Senior Regulatory Programs Manager
1 week ago
London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full timeSenior Global Program Regulatory ManagerJob ID: REQ-10016663Location: United KingdomSummaryOur Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and...
-
Regulatory Affairs Manager
4 weeks ago
London, Greater London, United Kingdom Turner Regulatory Full timePrincipal Regulatory Officer / EU; Pharma & Generic Products / Project ManagerHybrid Working - 1-2 days in the Office per week required. Supervision and mentoring of a small team.Overview:Excellent opportunity for a 'top end' Senior Regulatory Officer/Associate, with a background in European Market Regulatory activity.Liaise closely with Business...
-
Regulatory Affairs Manager
4 weeks ago
London, Greater London, United Kingdom Turner Regulatory Full timePrincipal Regulatory Officer / EU; Pharma & Generic Products / Project ManagerHybrid Working - 1-2 days in the Office per week required. Supervision and mentoring of a small team.Overview:Excellent opportunity for a 'top end' Senior Regulatory Officer/Associate, with a background in European Market Regulatory activity.Liaise closely with Business...
