Regulatory Affairs Manager - Novartis

Summary

• Registration of new drug products and maintenance of approved drug licenses to ensure availability of these products in the countries.
• Maintain good relationship with the HA to enhance prompt registration of new products and maintenance of product licenses.
• Maintain all necessary Novartis databases (e.g. DRAGON) to ensure regulatory compliance at all time.
• Maintain open communication with the different stakeholders and regularly provide information when required.
• Liaison between different stakeholders on regulatory matters.
• Supporting Clinical Trial applications in Ghana.
  
  

About The Role

Major Accountabilities:

• To support the planning and co-ordination of submission of drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve approval in line with planned registration timelines.
• To ensure (thorough follow up) that documents for new registration and reregistration are requested and received to ensure submission is achieved by due dates.

• To ensure that submissions for license renewal are done in good time before license expiry so as to achieve approvals and to avoid Top line impact due to license expiry
• To ensure submissions for production transfers and pack size extension are made and approvals received by due dates.
• To apply for and get approvals for pre-license promotion through named patient basis or orphan drugs when required.
• Ensure compliance to current local regulations and communication of any changes that may impact Novartis in a timely manner to all relevant Stakeholders.
• Support the update local/Regional Working Practices or SOPs when required.
• Ensure adherence to Global and local/regional processes.
• Ensure prompt submission of post approval commitments, PSUR submissions, RMP submissions, SLC updates and ensure timely responses to HA as required.
• Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary.
• Ensure compliance to global and local KPIs.
• Review and approval of marketing promotional materials when assigned by RA Head
• Develop and maintain good working relationships with other Novartis functions/departments both locally and globally, as well as with health authority and industry bodies, such as AREPI.
• Support our distributors on regulatory issues as assigned by RA Head
• Support Novartis culture including promotion of diverse and inclusive environment, free from all forms of discrimination and harassment.
  
  

Key Performance Indicators

• Meeting the registration submission due dates for products planned for launch each year.
• Meeting the registration approval dates for products planned for launch each year.
• Meeting product re-registration due dates and ensuring that no adverse impact occurs due to loss of license
• Maintaining minimum of 95% DRAGON compliance in update of new received post distribution changes to normal country folders and brand safety folders
• Keeping and improving strong relations with Health Authority's officials.
• Achievement of Regulatory compliance deliverables as per global targets
• Address issues related to compliance with urgency with escalations as appropriate.
• Product Deliveries to the markets according to plans (no stock outs due to out of compliance)
• Share emerging regulatory intelligence with the RA Head.
  
  

Ideal Background

Education (minimum/desirable): B. Pharm or BSc.

Languages: Fluent in English (mandatory)

Experience

• Minimum 3-5 years regulatory and drug/biologics development experience.
• Health Authority experience desirable.
• Good communication and negotiation skills.
• Good inter-personal skills.