Regulatory Affairs Manager

Summary

The RA Manager will be responsible to develop & execute submission & approval strategy for all regulatory activities & to ensure ethical conduct and compliance with applicable national and international laws, codes and regulations.

About The Role

• Manage, supervise and coach DRA associates to achieve the business objectives in term of new Launches and life cycle maintenance activities.
• Provide adequate training and guidance to all junior regulatory associates as relevant
• New Product Registrations – With no supervision, set up the strategy evaluate, prepare and submit drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favorable outcome
• Maintenance of registered products – With no supervision, maintain registration of currently approved products
• Product Information and Consumer Information – With no supervision, maintain product information and consumer information ensuring the correct use of the approved versions of these documents
• Relationships within and outside the company - Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with health authority and industry bodies, such as the SFDA.
• Provide valuable regulatory advice as necessary.
• Assist Medical Information and Quality Assurance with product detail requests wherever feasible.
• Ensure the compliance of Regulatory database system’s content & data maintenance activities (Dragon, Regulatory Intelligence Database ...etc.).
• Create, maintain, Review & approve products artworks & leaflets & set-up the proper plan for implementation.
• Create, review & maintain BSS for all promoted products.
• Review and approve Printed Packaging Material Sheet (PPMS) received via AQWA.
• Monitor, Communicate & distribute All SFDA new regulations & guidelines among all the concerned departments in the CPO, Regional RA team and Global RA team.
• Review, Analyze and implement All SFDA new regulations & guidelines.
• Review & approve promotional materials & activities in compliance with applicable company & country regulations & policies.
  
  

Key Performance Indicators

• The timely registration of new drug products.
• Accurate & timely maintenance of products life cycle management.
• Accurate & timely update for Novartis products labels, leaflets and safety information.
• Timely & accurate development & implementation of new artworks for leaflets & folding boxes.
• High regulatory compliance percentage for SALTO reports & DRAGON & all other relevant databases.
• Keep the relation with all related parties (inside & outside NVS) at the top level of respect, confidence & reliability.
• Performance management and coaching of the relevant DRA team.
• High regulatory compliance percentage for SALTO reports & DRAGON.
• Compliance of the promotional materials with the registered/approved PI.
  
  

Ideal Background

Education

• Bachelor Degree in pharmacy or any equivalent degree.
• Master degree is preferred.
  
  

Experience

• 5-7 Years in Regulatory Field.
• Deep understanding of SFDA and GCC regulatory system and rules.
• Strong Management skills.
• Excellent organization skills and ability to work on a number of projects with tight timelines is required.
• Strong Negotiation & Analytical skills
• Strong Interpersonal & Communication skills
• Excellent Computer skills (Word, Excel & PowerPoint).
• Fluent in Spoken & Written English.
  
  

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

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