At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Cairo, Egypt

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Regulatory Affairs Lead (JENA cluster), based in our office in Cairo, Egypt.

Key Responsibilities:

• Provide strategic leadership for Marketing Authorization applications, life cycle management, and labeling updates across the Jordan & East North Africa cluster (Jordan, Egypt, Sudan, Libya, and Ethiopia), ensuring compliance with local regulations and alignment with company objectives.

• Oversee and guide the preparation, review, submission, and follow-up of regulatory files, ensuring high-quality standards and timely execution.

• Act as a key liaison with Health Authorities, building strong relationships and influencing regulatory outcomes.

• Drive strategic alignment for new product submissions with global teams and internal stakeholders.

• Lead cross-functional collaboration with supply chain, marketing, commercial, and market access teams to ensure seamless regulatory processes.

• Ensure all regulatory activities comply with relevant laws, regulations, and company guidelines.

• Manage complex projects efficiently, demonstrating excellent project management skills and the ability to prioritize multiple tasks under tight deadlines.

• Provide indirect leadership by influencing and guiding teams across different functions without direct reporting lines.

• Maintain and enhance regulatory systems and databases, ensuring accurate and timely updates.

Required Qualifications & Skills:

• Pharmacy degree (or equivalent) with a minimum of 9 years of regulatory experience.

• Proven track record of managing multiple projects and delivering results in a fast-paced environment.

• Exceptional project management skills with the ability to lead initiatives from planning to execution.

• Strong indirect leadership capabilities, influencing cross-functional teams effectively.

• Excellent communication skills (verbal and written) for engaging internal and external stakeholders.

• Advanced analytical and problem-solving skills, with the ability to identify gaps and develop innovative solutions.

• Comprehensive knowledge of regulatory requirements, MOH regulations, and industry guidelines.

• High proficiency in digital tools and regulatory systems.

Leadership Competencies:

• Strategic Thinking: Ability to anticipate regulatory trends and align strategies with business objectives.

• Influencing Skills: Effectively guide and motivate cross-functional teams without direct authority.

• Decision-Making: Make sound, timely decisions under pressure while balancing compliance and business needs.

• Stakeholder Management: Build strong relationships with internal teams and external authorities to achieve shared goals.

• Change Leadership: Drive and manage organizational changes smoothly, ensuring team adaptability.

• Collaboration: Foster a culture of teamwork and knowledge sharing across diverse functions.

• Results Orientation: Maintain focus on delivering high-quality outcomes within agreed timelines.

 

 

Required Skills:

 

 

Preferred Skills: