Sr Dir, EMEA Emerging Markets Reg Affairs – Global Jobs

Kizuna Edge Talent Hub; Belgique; À distance; EUR 150 000 - 250 000; Plein temps

Résumé du poste

KETH Africa seeks a Senior Director, Head of EMEA Emerging Markets Regulatory Affairs to lead regulatory strategy across Africa, the Middle East, Türkiye, and the CIS. The role supervises ~80 colleagues, manages ~USD 10 million in budgets, and ensures compliance while partnering with global and regional teams.

Based in one of the EM locations, the role requires strong leadership, negotiation with health authorities, and a deep understanding of drug development, submissions, and lifecycle

Qualifications

• Advanced degree in science, health, pharmacy, medicine, or another relevant field.
• At least 15 years of relevant pharmaceutical industry experience with Regulatory Affairs.
• Experience leading regulatory strategy across multiple countries and product lifecycles.
• Emerging Markets experience with regional and country laws, health-authority expectations, and access considerations.

Responsabilités

• Lead regulatory strategy and execution across Africa, the Middle East, Türkiye, and Russia, and oversee Global Health Equity licenses.
• Manage a ~USD 10 million regulatory budget with long-range planning and governance.
• Guide interactions with health authorities and senior leaders while ensuring regulatory independence and compliance.
• Forecast demand and allocate resources for major filings and lifecycle activities across regional and country teams.
• Build and develop a high-performing regulatory organization with clear accountability and succession plans.

Connaissances

Regulatory strategy

Global health equity

Stakeholder management

Budget management

Cross-functional leadership

Health authority negotiation

Formation

Advanced degree in science/health/pharmacy/medicine

Description du poste

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 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.

Required Skills

Preferred Skills:

Business Writing, Compliance Risk, Cross-Functional Work, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Management, Strategic Thinking

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