Regulatory Affairs Manager- ESA at Novartis

Major accountabilities:

• Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.
• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
• Partners with regions to align on regulatory strategy in order to fulfil business objectives -Implements RFP across assigned regions.
• Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
• Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
• Develops and implements plans for timely response to HA requests and coordinates responses.
• May serve as local HA liaison depending on location (e.g., FDA or EMA).
• Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
• Review of global dossier summary documents.
• Develops and implements plans to avoid/minimize clock stops during submission review.
• Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
• Reviews and submits Risk Management Plans.
• May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.
• Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.
• Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity -Contributes to and often leads the development of departmental goals and objectives.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
• Identification of main HA issues
• Participation in relevant regulatory Boards leading to valuable input from these Boards.
• Successful Participation in HA interactions to achieve business objectives.
• Adherence to Novartis policy and guidelines

-Project & stakeholder feedback
Minimum Requirements:

Education:

• B. Pharm or life sciences degree or equivalent.

Work Experience

• Minimum 3-7 years’ experience in pharmaceutical regulatory affairs environment.
• Experience as RA Manager and managing direct reports would be an advantage.
• Knowledge and experience: Knowledge of Regulatory requirements for Medicines in the East and Southern Africa/ EAC, Ethiopia & SADC countries
• A good understanding of pharmacology, pharmaceutical and clinical data, and the pharmaceutical market
• Ability to implement and drive execution.
• Skills: Analytical and Interpretive; Detail oriented and organized; Ability to set standards and objectives and monitor progress; Prioritize workload to tight deadlines; Excellent communication; Cross functional ability/Good interpersonal skills; Innovative, problem solving and decision-making ability.