Senior Regulatory Affairs Professional SSA

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Learn more at scope: - Sub Saharan Africa Cluster (Kenya Nigeria and Ghana) within the EMEA Emerging Markets region.

The Senior Regulatory Affairs Professional: EMEA Emerging Markets Sub Saharan Africa Cluster is responsible for setting the regulatory strategy and leading regulatory affairs activities in Sub Saharan Cluster including Ghana Kenya and Nigeria markets.

The role is to drive the strategic agenda for the Regulatory Affairs Function in SSA in support of the Commercial business strategy within the market scope. The role reports directly to the Director Regulatory Affairs EMEA Emerging Markets Africa Clusters.

he role acts as the regulatory lead for the SSA Markets ensuring the development and execution of regulatory strategy operations and compliance activities. The role acts as a key member of the Regulatory Affairs Cluster Value Team (RA CVT) and as the Sr Regulatory Professional for all Therapeutic Areas (of registred products in the market).

The role acts as the primary liaison between Local Operating Companies (LOCs) and regional and global functions including Therapeutic Area teams CMC teams Labelling teams and Regulatory Quality groups. The role ensures timely and compliant regulatory support for tenders daily business needs and product supply in line with J&J guidelines and all applicable local regulations.

The role ensures optimal compliance with local regional and Johnson & Johnson regulatory requirements to minimize risks for patients and the business. The role also acts as a leader or active contributor in key ongoing projects to support organizational priorities and strengthen regulatory excellence across the cluster.

Responsibilities may also extend beyond the direct scope including support to crosscluster interactions and optimization initiatives across the Africa Cluster. This may involve participation in assigned projects at LOC level collaboration with crossfunctional teams and activities aimed at strengthening process compliance within the Africa Cluster as required.

Key responsibilities:

1. Act as Regulatory Cluster Value Team (RA CVT) Member and Sr RA Professtional for All Therapeutic Areas

• Provide strategic and relevant regulatory input to the CVT and Value Excellence teams.

• Understand business priorities commercial strategies and market drivers for SSA.

• Collaborate horizontally with Commercial Medical Affairs Government Affairs Supply Chain QA/BQ HR and other internal partners; and vertically with IBVTs and Brand Teams to support CVT strategy execution.

• Represent Regulatory Affairs in crossfunctional project teams and provide regulatory guidance for project plans target product profiles and lifecycle decisions.

• Lead and coordinate the business planning exercise en coordination within the CVT (for the Business plannig and the long range forecast)

2. Ensure Timely Registration of New Products

• Execute regulatory plans and manage timelines to deliver registration goals in SSA markets.

• Coordinate the preparation review submission and followup of registration dossiers in line with local regulatory requirements in Nigeria Ghana and Kenya.

• Track submissions and follow up with local MAHs/distributors on variations responses to HA queries and administrative updates.

• Share official Health Authority communications and updates with relevant internal stakeholders.

• Maintain close contact with partners to ensure timely submission reporting and escalation when required.

3. Maintain and Monitor Lifecycle Activities for Marketed Products

• Coordinate the preparation submission and followup of lifecycle management activities in compliance with local regulations and internal procedures.

• Share HA notifications and ensure timely and accurate responses to all HA queries.

• Maintain strong followup with MAHs/distributors to ensure adherence to timelines and compliance expectations.

4. Act as Primary Liaison Between SSA LOCs and International / External Stakeholders

• Keep the EMRL and global/regional partners informed of regulatory status risks and key updates across SSA markets.

• Ensure timely clear and transparent communication of priorities and decisions with internal stakeholders (CVTL TAL EMRL BUM MA CQ PV Medical).

• Participate in external industry groups and share insights internally in a structured and compliant manner.

5. Maintain Regulatory Archiving Databases and Systems

• Ensure proper electronic and paper tracking of regulatory activities marketing authorizations and lifecycle changes using approved systems.

• Update J&J regulatory databases according to company processes.

• Maintain update and use tracking tools and information systems to ensure accuracy and audit readiness.

6. Ensure Compliance With Internal and External Requirements

• Ensure all safety reporting (AE/PQC) in alignement with PV requirements are fulfilled according to SOPs and that these expectations are integrated when planning or executing activities.

• Ensure full compliance with HCC and legal requirements including FMV ToV and promotional material rules when working on projects materials or vendor contracts.

• Maintain inspection readiness through uptodate mandatory training current CV and an accurate job description.

Required Qualification and Core Competencies for the role:

• A minimum of a university degree - medical or paramedical (pharmacy biology veterinary etc.)

• Significant experience (5 years) in Regulatory affairs within the pharmaceutical industry and a proven track record of outstanding approvals

In-depth knowledge of the regulatory environment guidelines and practice of African region is required.

Reliable positive energized and self-motivating personality team-player

Strong communication and presentation skills with the ability to convert complex data in simple messages diplomacy and interpersonal adaptability

Ability to adapt communication style based on audience and situation

Integrity and transparency

Excellent English verbal and written communication skills are required. French and Arabic are preferable.

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