Sr Dir, EMEA Emerging Markets Reg Affairs

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category People Leader All Job Posting Locations: Beerse, Antwerp, Belgium, Beirut, Lebanon, Cairo, Egypt, Casablanca, Morocco, Dubai, Dubai, United Arab Emirates, Istanbul, Turkey, Johannesburg, Gauteng, South Africa, Riyadh, Saudi Arabia 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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all postings, we recommend focusing on the country or countries that align with your preferred location: • Belgium: R-103742 • UAE: R-106125 • Saudi Arabia: R-106130 • Turkey: R-106141 • Egypt & Lebanon: R-106129 • Morocco: R-106127 • South Africa: R-106135 Whether you apply to one or multiple requisition numbers, your applications will be considered as a single submission. We are searching for the best talent for the Senior Director, Head of EMEA Emerging Markets Regulatory Affairs role. The position may be based in any of the listed countries, with Emerging Markets (EM) locations preferred to ensure appropriate proximity to key stakeholders. Candidates must be currently based in one of the listed locations. Purpose The Senior Director, Head of EMEA Emerging Markets Regulatory Affairs leads regulatory strategy and execution across continental Africa, the Middle East, Türkiye, and Russia and the Commonwealth of Independent States. The role also provides regulatory leadership for remaining Global Health Equity licenses and markets. Reporting to the Vice President, Head of Regional Regulatory Affairs, with a dotted-line relationship to the Executive Vice President, Emerging Markets, this leader aligns regional and country strategies with portfolio priorities, patient access, product launches, lifecycle management, and sustained compliance. The role leads approximately 80 colleagues through direct and matrix relationships and is accountable for approximately USD 10 million in regional, local, and Global Health Equity regulatory budgets. This leader sets priorities, deploys resources, builds organizational capability and succession, and represents Regulatory Affairs in senior cross-functional decisions. You will be responsible for • Leading and developing a high-performing, inclusive regulatory organization across regional, cluster, and country teams, with clear accountability, decision rights, performance expectations, and succession plans. • Setting and executing regulatory strategy across development, evidence generation, filing sequence, registration, launch, labeling, portfolio optimization, and lifecycle management for all therapeutic areas in scope. • Enabling timely submissions, approvals, launches, and patient access through high-quality multinational and country strategies, including appropriate use of reliance, work-sharing, abridged, and other accelerated pathways in support of and aligned to the EM commercial strategy. • Making informed trade-off decisions across portfolio, market, resource, compliance, and business priorities, and escalating material risks with clear options and recommendations. • Advising senior commercial, research and development, medical, market access, safety, quality, supply chain, and Global Health Equity leaders while maintaining regulatory independence and compliance. • Representing Regulatory Affairs in portfolio, launch, evidence, supply-network, licensing, due-diligence, and business-development decisions, ensuring regional and country requirements are considered early. • Forecasting demand and deploying resources for major filings and lifecycle activities, in partnership with local managing directors, cluster leaders, and country regulatory heads. • Managing approximately USD 10 million in regulatory budgets, including long-range planning, funding decisions, and disciplined financial oversight. • Maintaining compliance across submissions, regulatory commitments, registrations, labeling updates, variations, renewals, translations, artwork, and other lifecycle obligations. • Ensuring effective controls, training, inspection of readiness, remediation, performance data, and fit-for-purpose systems across the region. • Building senior relationships with health authorities and guiding key interactions and negotiations in partnership with global, regional, and country teams. • Assessing emerging legislation, guidance, review practices, and policy trends, translating them into clear implications for development, registration, lifecycle, supply, and access strategies. • Shaping the external regulatory environment through health authorities, trade associations, industry coalitions, and other relevant stakeholders. Required Qualifications / Requirements • An advanced degree in science, health, pharmacy, medicine, or another relevant field is required. • At least 15 years of relevant pharmaceutical industry experience, including substantial experience in Regulatory Affairs. • Demonstrated success leading regulatory strategy and execution across multiple countries, therapeutic areas, and product lifecycle stages. • Relevant Emerging Markets experience, with a strong understanding of regional and country laws, health-authority expectations, business practices, and access considerations. • Significant experience interacting and negotiating with health authorities and representing a company at senior level. • Deep knowledge of drug development, registration, submissions, labeling, data management, lifecycle management, and regulatory compliance. • Demonstrated experience leading process optimization, including the adoption of automation and artificial intelligence (AI), to deliver measurable improvements in regulatory efficiency, quality, and execution while maintaining appropriate governance and compliance. • Experience leading multicu

An advanced degree in science, health, pharmacy, medicine, or another relevant field is required. At least 15 years of relevant pharmaceutical industry experience, including substantial experience in Regulatory Affairs. Demonstrated success leading regulatory strategy and execution across multiple countries, therapeutic areas, and product lifecycle stages. Relevant Emerging Markets experience, with a strong understanding of regional and country laws, health-authority expectations, business practices, and access considerations. Significant experience interacting and negotiating with health authorities and representing a company at senior level. Deep knowledge of drug development, registration, submissions, labeling, data management, lifecycle management, and regulatory compliance. Demonstrated experience leading process optimization, including the adoption of automation and artificial intelligence (AI), to deliver measurable improvements in regulatory efficiency, quality, and execution while maintaining appropriate governance and compliance. Experience leading multicountry/regional regulatory programs and budgets.

Leading and developing a high-performing, inclusive regulatory organization across regional, cluster, and country teams, with clear accountability, decision rights, performance expectations, and succession plans. Setting and executing regulatory strategy across development, evidence generation, filing sequence, registration, launch, labeling, portfolio optimization, and lifecycle management for all therapeutic areas in scope. Enabling timely submissions, approvals, launches, and patient access through high-quality multinational and country strategies, including appropriate use of reliance, work-sharing, abridged, and other accelerated pathways in support of and aligned to the EM commercial strategy. Making informed trade-off decisions across portfolio, market, resource, compliance, and business priorities, and escalating material risks with clear options and recommendations. Advising senior commercial, research and development, medical, market access, safety, quality, supply chain, and Global Health Equity leaders while maintaining regulatory independence and compliance. Representing Regulatory Affairs in portfolio, launch, evidence, supply-network, licensing, due-diligence, and business-development decisions, ensuring regional and country requirements are considered early. Forecasting demand and deploying resources for major filings and lifecycle activities, in partnership with local managing directors, cluster leaders, and country regulatory heads. Managing approximately USD 10 million in regulatory budgets, including long-range planning, funding decisions, and disciplined financial oversight. Maintaining compliance across submissions, regulatory commitments, registrations, labeling updates, variations, renewals, translations, artwork, and other lifecycle obligations. Ensuring effective controls, training, inspection readiness, remediation, performance data, and fit-for-purpose systems across the region. Building senior relationships with health authorities and guiding key interactions and negotiations in partnership with global, regional, and country teams. Assessing emerging legislation, guidance, review practices, and policy trends, translating them into clear implications for development, registration, lifecycle, supply, and access strategies. Shaping the external regulatory environment through health authorities, trade associations, industry coalitions, and other relevant stakeholders.