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Regulatory Policy Manager
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Regulatory Reporting Manager
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eFinancialCareers London, United Kingdom**Regulatory Reporting Manager - Investment Banking - City of London - Salary up to £90,000** · A London-based global Investment Bank with operations in Fixed Income, Commodities and FX is looking to hire a Manager into their Regulatory Reporting function. · This will be a broad ...
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Regulatory Compliance Manager
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Cosmetic Regulatory Manager
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Regulatory Complaints Manager
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Regulatory Affairs Manager
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Regulatory Project Manager
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Regulatory Reporting Manager
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Regulatory Panel Manager
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Nutrition and Regulatory Manager
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Regulatory Panel Manager
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Regulatory Communications Manager
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Regulatory Reporting Manager
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Regulatory Reporting Manager
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Liquidity Regulatory Policy Manager
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Senior Regulatory Affairs Manager
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CK GROUP London, United KingdomCK Group are recruiting for a Senior Regulatory Affairs Manager to join a highly successful pharmaceutical company with a strong portfolio of marketed and developmental products. This is an exciting time for the company as they move to later phase developmentand marketing authori ...
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Regulatory License Project Manager
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Liquidity Regulatory Reporting Manager
4 days ago
eFinancialCareers London, United KingdomOur client is a mid-sized UK banking group looking for a Liquidity Regulatory Reporting Manager · The focus of the role is to ensure that the Bank is compliant with all relevant financial regulation, including the preparation of reporting to the PRA. Furthermore, they will provid ...
Senior Global Program Regulatory Manager - United Kingdom - Novartis Farmacéutica
Description
Senior Global Program Regulatory Manager - Immunology
Job ID 394169BR
Mar 28, 2024
United Kingdom
About the Role
1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. We also focus on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.
The Sr GPRM works under limited supervision of the regulatory affairs (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). They may act as the RA program lead on programs of limited complexity. The Sr GPRM is a member of the RA sub team and may lead or represent RA in regional or cross-functional teams. They may also act as a subject matter expert and/or assume mentoring role. Major accountabilities: Regulatory Strategy• Provides input to global program regulatory strategy, including regulatory designations & innovative approaches
• May provide global RA leadership for specific part of the program or act as RA program lead for program of limited complexity
• Represents RA or leads in regional RA or cross-functional activities
• Determines requirements and coordinates activities for Health Authority (HA) interactions. May lead HAs meetings together with RA program lead.
• May serve as local HA liaison (e.g., FDA or EMA). Regulatory Submissions
• Leads planning, preparation and submission of clinical trials.
• Coordinates, plans, and prepares for submission of initial registration and post-approval applications, including authoring of Module 1 documents Regulatory Excellence and Compliance
• Ensures timely RA input and submission of regulatory compliance and maintenance reports (e.g. aggregate safety reports, annual reports, renewals, etc) across assigned regions
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Education
Bachelors degree preferred (Minimum/desirable)
• Science based BS or MS. Advanced degree (e.g., MD, PhD, PharmD, regulatory) preferred
• Advanced understanding of pharmaceutical development, clinical trials, analysis and interpretation of scientific data
• Awareness of post-marketing/brand optimization strategies and commercial aspects.
• ≥4 years involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major region.
• Experience in leading cross-functional teams
• Strong collaboration, communication influencing and problem solving skills.
• Organizational awareness (e.g., interrelationship of departments, business priorities)
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis
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:
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