Senior Manager

2 weeks ago


London, Greater London, United Kingdom Novartis Farmacéutica Full time
Senior Manager Regulatory Affairs Process Excellence Job ID REQ
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.

We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.

We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.

This role offers hybrid working, requiring 3 days per week in our White City, London office.

In this role you will be responsible for leading the development and implementation of enhanced regulatory quality processes and procedures within Region Europe and Basel HQ.

You will align across functions and support the implementation of initiatives within RA Global Drug Development to support a quality system, having established and maintained a comprehensive set of clear, consistent EU RA policies and procedures that align with global functions, both within and external to RA, and across Novartis Business Units.

You will prepare the RA GDD organization for internal global audits in Basel HQ, collaborating with QA to prepare for external inspections for Region Europe and Japan.

You will be responsible for the creation, implementation and completion of relevant remedial and improvement actions from Corrective Action Plans following Audits/Inspections.

You will help country organisations prepare for internal audit, external inspections and CAPA proposals as needed.

You will ensure the timely management of deviations/ incidents, enhancing the quality and consistency of RA compliance in region Europe and Basel HQ through the implementation of new processes, policies, metrics and appropriate training.

You will provide input into RA and cross functional SOPs and support the Regulatory Information Management Team ensure data compliance in HQ, Region Europe and Japan.

Pharmaceutical industry experience, with a minimum of three years in Regulatory Affairs.
Demonstrable experience in EU regulatory and drug development, working knowledge of SOPs and compliance.

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.

Commitment to Diversity & Inclusion :

Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.


Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.

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:
Business Unit Pharmaceuticals
Company / Legal Entity GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
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