Global Head of Regulatory Strategy

NonStop Consulting AG; Basel; Presencial; CHF 180.000 - 260.000; Jornada completa

Descripción de la vacante

NonStop Consulting AG is seeking a Global Head of Regulatory Strategy to shape and drive regulatory direction across an international pharmaceutical portfolio from Basel. This senior role combines strategic oversight with hands-on leadership of an experienced global team, influencing critical development and commercial decisions.

You will collaborate closely with Clinical Development, Medical Affairs, Quality and Commercial to ensure regulatory considerations are embedded in portfolio strategy

Formación

• Extensive Regulatory Affairs leadership experience in pharma.
• Proven track record delivering global regulatory strategies.
• Experience engaging with FDA/EMA and other authorities.
• Strong stakeholder management and executive influence.
• Bachelor's in a relevant science; PharmD/PhD preferred.
• Fluency in English.

Responsabilidades

• Define, lead and execute regulatory strategies across assets from development through lifecycle.
• Provide senior regulatory guidance to global development teams.
• Oversee high-level interactions with FDA, EMA and other authorities.
• Lead and mentor an international team of regulatory professionals.
• Collaborate with Clinical Development, Quality, Commercial and other global functions.

Conocimientos

Regulatory leadership

Strategic thinking

Stakeholder management

Team leadership

Regulatory strategy

Educación

Bachelor's degree in a scientific discipline

PharmD or PhD preferred

Descripción del empleo

Global Head of Regulatory Strategy

NonStop Consulting is partnering with an established international pharmaceutical organisation to appoint a Global Head of Regulatory Strategy.

This is a high-impact senior leadership opportunity for an accomplished Regulatory Affairs executive to shape and drive global regulatory strategy across an international pharmaceutical portfolio.

The successful candidate will play a pivotal role in defining regulatory direction, influencing critical development and commercial decisions, and ensuring the successful execution of regulatory strategies across key international markets.

In this senior leadership position, you will combine strategic oversight with hands‑on leadership, guiding an experienced international team and collaborating closely with key cross‑functional stakeholders.

Key Responsibilities

• Global Regulatory Strategy: Define, lead and execute comprehensive regulatory strategies across multiple assets, from clinical development through registration, commercialisation and lifecycle management.
• Strategic Leadership: Provide senior-level regulatory guidance to global development teams, ensuring regulatory considerations are embedded in key portfolio and business decisions.
• Regulatory Authority Engagement: Oversee high‑level interactions and negotiations with major international health authorities, including the FDA, EMA, PMDA and other relevant regulatory bodies.
• Global Team Leadership: Lead, develop and mentor an international team of senior regulatory professionals, fostering accountability, collaboration and high performance.
• Portfolio Oversight: Direct regulatory strategy and execution across key markets, including the US, Europe and selected international territories.
• Executive Collaboration: Contribute to global regulatory leadership decisions, resource allocation, risk management and long‑term functional strategy.
• Business Development Support: Provide strategic regulatory input into due diligence activities, potential licensing opportunities and portfolio assessments.
• Operational Excellence: continuous improvement, innovation and the responsible adoption of new technologies to enhance regulatory effectiveness.
• Cross‑Functional Partnership: Collaborate closely with Clinical Development, Medical Affairs, Quality, Commercial and other global functions to support business objectives.

Your Profile

We are seeking an experienced, commercially aware and strategically minded Regulatory Affairs leader with the credibility to operate at the highest levels of an international pharmaceutical organisation.

Essential experience and qualifications:

• Extensive experience in Regulatory Affairs within the pharmaceutical industry.
• Significant leadership and organisational management experience, ideally within an international regulatory function.
• Proven experience defining and delivering global regulatory strategies across complex pharmaceutical portfolios.
• Extensive experience engaging with major regulatory authorities, particularly the FDA and EMA, with broader international regulatory exposure.
• Strong understanding of global drug development, registration, commercialisation and product lifecycle management.
• Demonstrated ability to build, lead and develop international teams, including senior regulatory leaders.
• Excellent stakeholder management, influencing and negotiation skills, with experience contributing to executive‑level decision‑making.
• Strong strategic judgement, regulatory risk management capabilities and the ability to navigate complex development challenges.
• Bachelor's degree in a relevant scientific discipline required; PharmD, PhD or equivalent advanced qualification preferred.
• Fluency in English.
• Experience with specialised therapies, complex development programmes or niche therapeutic areas would be advantageous

Why Consider This Opportunity?

• Executive‑level influence: Play a key role in shaping global regulatory strategy and contributing to high‑level business decisions.
• International scope: Take ownership of regulatory strategy across multiple markets and a diverse pharmaceutical portfolio.
• Leadership impact: Lead and develop an established team of experienced regulatory professionals.
• Strategic visibility: Work closely with senior leadership and influence the direction of a global regulatory function.
• Innovation and transformation: Drive continuous improvement and contribute to the evolution of regulatory strategy and operational excellence.
• Meaningful impact: Support the development and successful commercialisation of innovative therapies for patients worldwide.

Confidential Application Process

This search is being managed on a strictly confidential basis by NonStop Consulting.
Further details regarding the organisation, leadership structure and strategic priorities will be shared with suitably qualified candidates during a confidential discussion.

• NonStop Consulting AG

3001 Bern

• Work location 4001 Basel (BS)
• Workload 80% - 100%
• Employment start By agreement
• Employment duration Permanent
• By online Online form