Global Program Regulatory Manager
Global Program Regulatory Manager
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Job Description
Band
Level 4Job Description Summary
Our Development Team is guided by our purpose: to reimagine medicineto improve and extend peoples 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 platform depth and capabilities all to bring our medicines to patientseven faster. As Global Program Regulatory Manager you will work with the support of a RA Program Lead to develop and implement the global regulatory strategy for program(s) through development registration and post approval in the assigned region(s).
Job Description
Regulatory Strategy
- Provide input to global program regulatory strategy including regulatory designations & innovative approaches.
- Coordinates regulatory readiness with other line functions Country Organizations & Regions representing RA or leads in regional RA or cross-functional activities providing strategic input into cross functional deliverables.
- Contributes to the development and maintenance of key documents determines the requirements and coordinates the activity for HA interactions.
Regulatory Submissions
- Leads planning preparation and submission of clinical trials.
- Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
- Coordinates plans and prepares for submission of initial registrations and post approval applications and the preparation review and maintenance of local product information as assigned.
- Lead regulatory activities during HA reviews responding to questions and HA interactions.
Regulatory Excellence & Compliance
- Ensures timely RA input and submission of regulatory compliance and maintenance reports maintaining regulatory information in compliance databases and document management systems.
Your Experience:
- Science based bachelors degree plus an understanding of pharmaceutical development clinical trials.
- Track record of involvement in regulatory or pharmaceutical development in one or more major regions.
- Strong interpersonal skills and experience working in a complex cross functional organization and leading cross function teams.
- Compliance and Quality mindset.
- Fluency in English.
Location: UK London Hybrid working requirement 3 days / 12 days per month in office.
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: to Diversity & Inclusion:
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
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Clinical Trials Detail-Oriented Drug Development Lifesciences Negotiation Skills Regulatory ComplianceRequired Experience:
Exec
Employment Type
Full-Time
