RA Manager, Procedural Documents

Our 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 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.

Apply today and welcome to where we thrive together!

About the Role

The role:

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

As a Manager Regulatory Affairs Procedural Documents, you will be responsible for creating, reviewing, and updating procedural documents for Regulatory Affairs (RA) owned processes. Your role will ensure compliance with relevant guidelines and regulations, and internal Novartis standards.,

• Professionally and consistently write clear, concise, and accurate RA owned procedural documents in alignment with respective functions.


• Coordinate with the subject matter experts (SMEs) and stakeholders to gather the necessary information and feedback for the document.


• Handle process timelines and requirements and obtain all approvals from impacted Functions and QA


• Lead the subject matter expert teams through the procedural update process and manage necessary steps in the applicable systems.


• Provide strategic recommendations for improving the RA procedural document landscape, identifying opportunities to streamline and simplify it.


• Provide efficient tracking and reporting of the procedural document status.
  
  Bachelor's degree in life science or related field.


• Pharmaceutical industry experience, preferably in regulatory affairs with experience in SOP writing.


• Knowledge of regulatory guidelines and standards e.g. FDA, EMA ICH etc.


• Good interpersonal, communication and negotiation skills. Ability to work independently.


• Experience of working in a complex, cross functional environment.


• Fluency in English (written and spoken)
  
  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? https://www.novartis.com/about/strategy/people-and-culture


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.

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: https://talentnetwork.novartis.com/network

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? https://www.novartis.com/about/strategy/people-and-culture

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: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Development
Business Unit
Innovative Medicines, Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.