Senior Global Program Regulatory Manager – Immunology

Job title:

Senior International Program Regulatory Supervisor – Immunology

Firm

Novartis

Job description

Concerning the function1,800+ associates. 86 nations. One Regulatory Affairs. At Novartis your voice, expertise, and high quality mindset can actually make a distinction in Regulatory Affairs (RA). Novartis has a novel and promising portfolio with 70 initiatives as potential NMEs in growth, 65 initiatives in Section 3 or already present process registration, and 100 Section 1/2 initiatives. We additionally deal with uncommon illness areas; in actual fact, greater than 80% of our innovation is focused on areas of excessive unmet want. In lots of circumstances, we will supply household pleasant work flexibility to facilitate your bodily and psychological well being. Learn on to study in regards to the function accessible in Regulatory Affairs. We hope you’ll think about becoming a member of our world OneRA household.The Sr GPRM works beneath restricted supervision of the regulatory affairs (RA) program result in develop and implement the worldwide regulatory technique for program(s) via growth, registration and put up approval within the assigned area(s). They might act because the RA program lead on applications of restricted complexity. The Sr GPRM is a member of the RA sub crew and will lead or signify RA in regional or cross-functional groups. They might additionally act as a subject skilled and/or assume mentoring function.Main accountabilities:Regulatory Technique

• Supplies enter to world program regulatory technique, together with regulatory designations & revolutionary approaches
• Could present world RA management for particular a part of this system or act as RA program lead for program of restricted complexity
• Represents RA or leads in regional RA or cross-functional actions
• Determines necessities and coordinates actions for Well being Authority (HA) interactions. Could lead HAs conferences along with RA program lead.
• Could function native HA liaison (e.g., FDA or EMA).

Regulatory Submissions

• Leads planning, preparation and submission of scientific trials.
• Coordinates, plans, and prepares for submission of preliminary registration and post-approval purposes, together with authoring of Module 1 paperwork

Regulatory Excellence and Compliance

• Ensures well timed RA enter and submission of regulatory compliance and upkeep reviews (e.g. combination security reviews, annual reviews, renewals, and so forth) throughout assigned areas

Function NecessitiesTraining
Bachelors diploma most popular (Minimal/fascinating)

• Science based mostly BS or MS. Superior diploma (e.g., MD, PhD, PharmD, regulatory) most popular
• Superior understanding of pharmaceutical growth, scientific trials, evaluation and interpretation of scientific knowledge
• Consciousness of post-marketing/model optimization methods and business points.
• ≥4 years involvement in regulatory and pharmaceutical growth spanning actions in Phases I-IV in 1 or extra main area.
• Expertise in main cross-functional groups
• Robust collaboration, communication influencing and downside fixing abilities.
• Organizational consciousness (e.g., interrelationship of departments, enterprise priorities)

Why Novartis?
766 million lives had been touched by Novartis medicines in 2021, and whereas we’re happy with this, we all know there may be a lot extra we might do to assist enhance and lengthen individuals’s lives.
We consider new insights, views and ground-breaking options might be discovered on the intersection of medical science and digital innovation. {That a} numerous, equitable and inclusive setting conjures up new methods of working.
We consider our potential can thrive and develop in an unbossed tradition underpinned by integrity, curiosity and suppleness. And we will reinvent what’s doable, once we collaborate with braveness to aggressively and ambitiously sort out the world’s hardest medical challenges. As a result of the best threat in life, is the chance of by no means making an attempt!Think about what you possibly can do right here at Novartis!Practical SpaceAnalysis & ImprovementDivisionImprovementEnterprise UnitREG AFFAIRS GDDEmployment KindCommonDedication to Variety & Inclusion:We’re dedicated to constructing an impressive, inclusive work setting and numerous groups consultant of the sufferers and communities we serve.Shift WorkNoEarly ExpertiseNo

Anticipated wage

Location

London

Job date

Sat, 30 Mar 2024 07:15:20 GMT

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