Associate Director, Regulatory Affairs Policy & Strategy SSA at Novartis International AG

Job ID: 322606BR
Employment Type: Regular
Division: Global Drug Development
Functional Area: Research & Development
Business Unit: REG AFFAIRS GDD
Shift Work: No

Job Purpose

• The Associate Director RA Policy and Strategic Operations is a critical member of the RA SSA team, responsible for enhancing/improving processes that support strategic planning of regulatory activities in Sub Saharan Africa region (SSA).
• The Associate Director RA Policy and Strategic Operations SSA works with internal and external stakeholders providing strategic and operational regulatory direction for clinical trial expansion in Sub-Sahara Africa (SSA), 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.
• Drive the successful implementation of regulatory strategy for clinical trials expansion in assigned countries within SSA, partnering with internal and external stakeholders to identify gaps, and put in place capability building initiatives internally and externally.
• Establish and maintain relationships with key external stakeholders such as Regulators, Industry Trade Association, NGO’s to enable and facilitate robust regulatory policy.
• Represent Novartis on assigned workstreams within trade associations and actively shape the policy agenda.
• Oversee collection and maintenance of regulatory requirements, monitor internal and external solution trends (CTA Hub, third party etc.).Provide Subject matter expertise to global and local teams on developing and adapting regulatory solutions, reliance models and regional pathways for specific development program to support clinical trials and New Drug Applications.
• Streamline the regulatory operations and oversee the regulatory compliance within SSA.
• Act as project manager for key projects and initiatives e.g. streamlining operations, acceleration of key submission projects and policy initiatives.
• Develop and drive complex projects/initiatives to enhance processes and/or tools for strategic planning of regulatory activities in SSA.
• Lead regulatory capability building initiative for SSA by anticipating needs to support regulatory system strengthening.

Minimum Requirements

• Education: Science-based, B.Sc or M.Sc. Pharmacy Degree is desirable.
• Languages: Fluency in English as a business language. French is a plus.
• Experience: Minimum 5 -7 years of regulatory and drug/biologic development experience, Health Authority experience desirable.
• Demonstrable history of success over multiple years in a regulatory including understanding of drug development and clinical trials.
• Strong 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 and in global teams.
• Good management, interpersonal, communication (both verbal and written), negotiation and problem-solving skills.