Sr Dir, EMEA Emerging Markets Reg Affairs

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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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: 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.

Qualifications / Requirements

Required

• 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 multicultural geographically dispersed teams through direct and matrix relationships including talent development performance management succession and organizational design.

• Strong financial resource project risk and change-management capabilities.

• Excellent English communication executive presence stakeholder management influencing negotiation and conflict-resolution skills.

• Ability to simplify complex issues establish clear governance make principled decisions and deliver outcomes in ambiguous high-risk situations.

• Demonstrated commitment to patients quality ethics compliance inclusion and psychologically safe collaboration.
  

Preferred

• Broader regional and global Regulatory Affairs experience.

• Experience in a local operating company and/or regulatory agency.

• Knowledge of reliance work-sharing and other accelerated regulatory pathways.
  

Other

• The role requires approximately 15-25% travel within the EMEA region and internationally.

• The position operates with a high degree of independence across a geographically dispersed matrixed organization.

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