Head of Regulatory affairs

We, at Janssen Egypt, are 150+ passionate employees working tirelessly to make the world a better place and to treat, cure, stop and prevent some of the most devastating and complex diseases of our time — from immune-mediated diseases and cancers to mood disorders, pulmonary arterial hypertension, and HIV. At Janssen, we never stop working toward a future where the disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We are Janssen. We collaborate with the world for the health of everyone in it. Visit us: http://www.janssen.com/emea/

Position Summary :

The Head of Regulatory Affairs JENA will be responsible for leading regulatory affairs activities in the cluster for the Janssen portfolio and support the local GPH regulatory team (limited support) as required striving for convergence in ways of working. The JENA cluster comprises Egypt, Libya, Sudan, Ethiopia, and any new business within the geographical scope.

The position may also have Local QP responsibility.

This role is ultimately accountable for the local Regulatory Affairs team activities in the JENA cluster including filing strategy and compliance. You should work via efficient management of a team and ensure the team is well equipped for execution and coached through Credo-based management.

Main responsibilities:

Strategic and tactical input in development, filing , and post-approval and Life cycle management:

• Develop and ensure effective implementation of regional, central and national regulatory strategy and tactics in support of the global development and filing strategy and life-cycle management plan
• Develop and implement country objectives based on Janssen business priorities, and global regulatory strategies and plans
• Align with Regional organizations to create a country-specific regulatory strategy for registering new products and existing products
• Provide leadership through extensive interdependent partnering, benchmarking, demonstrating standard processes, and forming strategic alliances with cross-functional partners to drive key business goals and objectives
• Coordinate with other Regional RA leaders as appropriate to develop and harmonize efficient processes and ways
• Drives effective business strategies to ensure regulatory programs and projects within JENA are standardized to acquire the earliest possible approvals.
• Provides measurable input into the development and implementation of Regulatory Affairs processes, standards, or plans in support of the organization’s strategies.
• Provides overall management of staff development and team budget to support business objectives.
• Serve as primary Regulatory liaison for the JENA cluster and be an active participant on the Cluster leadership team (JENA LT)

Liaison with Regulatory Agencies

• Establish and maintain positive relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments either directly or via delegation to the team.
• Develop a deep understanding of the regional regulatory environment, and competitor intelligence across therapeutic areas in the market scope.
• Ensure appropriate implementation of scientific advice/Regulatory Agency comments into the development and life-cycle management plan of the portfolio in scope.

Clinical Trial Applications (CTA)

• If applicable, ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement, and competitive labeling

Talent and Development

• Ensure training and provide leadership to the team to ensure talent development and experience sharing within the cluster and wider region
• Ensure a pipeline of succession planning within the JENA cluster
• Ensures team diversity and builds a culture of innovation in line with Johnson and Johnson Credo values
• Identify, set, and supervise individual objectives and the means of implementation
• Implement vital actions to ensure a positive environment and business continuity
• Coordinate and facilitate team meetings and teamwork
• Conduct evaluation of reports on a regular basis and establish salary recommendations