Regulatory Affairs Senior Manager, Sub‑Saharan Africa

Job Description Summary

Leads regulatory submission activities across the product lifecycle, providing strategic guidance to project teams and acting as the primary liaison with regulatory agencies to negotiate requirements and expedite approvals.
Ensures timely approval and ongoing compliance while advise the development and marketing teams on regulatory implications of related changes, labeling and line extensions and coordinates, reviews and prepares regulatory documentation and reports for submission.

Job Description

• Responsible for implementing regulatory strategy and managing operational activities for the assigned SSA countries.
• Responsible to coordinate and follow up with all responsible distributors and local representatives and scientific offices on the geographical region of SSA.
• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for the assigned SSA countries.
• Find synergies between countries, align with different stakeholders to obtain approvals and unlock struggles with appointments and long timelines.
• Partners with regions align regulatory strategy in order to fulfil business objectives -Implements Regulatory Functional Plan across the assigned SSA countries.
• Determines requirements and sets objectives for Health Authority interactions .
• Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
• Develops and implements plans for timely response to Health Authority requests and coordinates responses.
• Drives coordination, planning, and submission of dossiers in the assigned SSA countries.
• Review of global dossier summary documents.
• Develops and implements plans to avoid/minimize clock stops during submission review.
• Responsible to maintain KPIs of all compliance and safety metrics from regulatory perspective.
• Responsible for facilitating timely submission and approval of dossier with Health Authority under the guidance of the global and regional RA
• 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.

 

Key performance indicators:

• Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
• Successful management of local distributors and scientific offices in countries and ensure KPI monitoring and stakeholder management.
• Identification of main Health Authority issues
• Participation in relevant regulatory Boards leading to valuable input from these Boards.
• Successful Participation in Health Authority interactions to achieve business objectives.
• Adherence to Sandoz policy and guidelines
• Project & stakeholder feedback

 

Minimum Requirements

• Bachelor’s degree in pharmacy or related field
• 7+ years of relevant regulatory experience with 3+ years in managerial role within pharmaceutical industry
• Experience in regulatory affairs in the region of SSA and working the distributors and country scientific offices.
• Excellent knowledge of local legislation requirements in the field of pharmaceutical registration
• Experience in interacting with government authorities
• Strong knowledge of labeling requirements and GxP documentations
• Attention to detail, organizational skills and ability to work with documentation
• Fluent in English and Arabic . French is a plus.

Skills Desired

Detail-Oriented, Drug Development, Lifesciences, Regulatory Compliance