RA Policy and Strategic Operations Manager - SSA at Novartis International AG

Job ID: 322523BR
Employment Type: Regular
Division: Global Drug Development
Business Unit: REG AFFAIRS GDD
Functional Area: Research & Development
Shift Work: No

Job Description
Job Purpose:

• The RA SSA Policy and Strategic Operations Manager is a key member of the RA SSA Policy & Strategic Operations Team responsible for supporting all process improvement activities and projects which enable strategic planning as well as compliance of regulatory activities in Sub Saharan Africa region (SSA).
• The RA SSA Policy and Strategic Operations Manager will monitor and communicate regulatory requirements, intelligence and policy to facilitate strategic planning for clinical trial expansion in SSA and key regulatory policy initiatives, including efforts to shape harmonization across SSA and strengthening regulatory capabilities

Major Accountabilities:

• The portfolio scope comprises of products from Innovative Medicines (Pharma and Oncology), Sandoz small molecules, biosimilars and Novartis Access brands.
• Support the successful implementation of regulatory strategy for clinical trials expansion in assigned countries within SSA.
• Identify and escalate emerging policy information and regulatory intelligence to the Head, RA Policy & Strategic Operations
• Coordinate RA SSA Policy and Clinical trial activities as required to ensure that set objectives are met
• Coordinate Artwork regional presentation activities in collaboration with cluster artwork coordinators
• Support development and maintenance of dashboards and trackers designed to improve regulatory processes within the Region
• Support collection and maintenance of regulatory requirements, monitor internal and external solution trends (CTA Hub, third party etc.)
• Support monitoring of regulatory compliance within SSA
• Support key projects and initiatives e.g. streamlining operations, acceleration of key submission projects and policy initiatives
• Prepare and coordinate Novartis feedback on draft legislation/guidelines
• Contribute to internal knowledge management systems and produce analysis reports when required
• Communicate new and emerging regulatory requirements to RA colleagues and relevant line functions via written communication such as newsletters, information e-mails.
• Support internal activities for the development of policy strategies and advocacy plans.
• Make presentations, as appropriate, as a means to communicate new or evolving regulatory requirements.

Minimum requirements

• Education: Science-based, BS or MS, Pharmacy Degree is desirable.
• Languages: Fluency in English as a business language. French is a plus
• Minimum 3 - 5 years of regulatory and drug/biologic development experience, Health Authority experience desirable.
• Good understanding of regulatory and legislative environment
• Knowledge and experience with local regulatory affairs and regulations
• Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally.
• Good management, interpersonal, communication (both verbal and written), negotiation and problem-solving skills.