Contract Opportunities

NEW: Global Regulatory Lead – Immunology

Contract: 24 weeks

Apply Now

Exclusive to The Source - register/apply now

We are seeking an experienced Global Regulatory Lead (GRL) to provide strategic regulatory leadership for an immunology development programme within a global pharmaceutical organization.

This is a senior-level opportunity for an accomplished regulatory affairs professional with a strong track record of developing and executing global regulatory strategies, leading cross-functional development teams, and engaging with health authorities across key markets.

The successful candidate will play a pivotal role in shaping the regulatory pathway for an immunology asset, providing strategic direction throughout clinical development and, where applicable, supporting registration and post-approval activities.

The role will suit an established regulatory leader who combines strong scientific and regulatory expertise with the ability to influence senior stakeholders, navigate complex global regulatory environments and drive programme objectives forward.

The Role

Global Regulatory Strategy

Develop, lead and execute the global regulatory strategy for an immunology programme across clinical development and the product lifecycle.
Provide strategic regulatory input into development plans, evidence generation, registration pathways and key programme milestones.
Assess regulatory risks, opportunities and potential challenges, providing clear recommendations to programme leadership.
Ensure regulatory strategies align with global development objectives and applicable regional requirements.

Cross-Functional Programme Leadership

Act as the Global Regulatory Lead within a multidisciplinary drug development team.
Collaborate with Clinical Development, Clinical Operations, CMC, Safety, Medical Affairs, Biostatistics and other functional stakeholders.
Provide regulatory oversight of key submissions, including IND/CTA applications, amendments, clinical development milestones and marketing applications, as applicable.
Translate complex regulatory requirements into clear, practical recommendations that support programme delivery and decision-making.

Global and Regional Regulatory Alignment

Drive alignment between global regulatory strategy and regional requirements.
Partner with regional regulatory teams to ensure consistent implementation of the global strategy.
Evaluate regional regulatory intelligence, emerging guidance and changes in regulatory expectations that may affect development plans.
Where relevant, facilitate effective communication across international teams, taking account of local regulatory processes and business practices.

Leadership and Stakeholder Management

Influence senior-level stakeholders and contribute to strategic programme decisions.
Lead regulatory discussions, challenge assumptions where appropriate and build consensus across cross-functional teams.
Mentor and support regulatory colleagues, sharing expertise and promoting strong regulatory practices.
Identify and proactively manage regulatory risks, dependencies and critical-path activities.

Requirements

Extensive experience in pharmaceutical or biotechnology regulatory affairs, ideally at Director or Senior Director level.
Demonstrated experience leading global regulatory strategy for drug development programmes.
Strong immunology experience, preferably supporting the development of innovative biologics or other advanced therapies within an immunology portfolio.
Experience working across clinical development and key regulatory milestones, with a strong understanding of global submission requirements.
Proven experience engaging with health authorities, particularly the US FDA.
Experience working within matrixed, multinational pharmaceutical organisations and leading cross-functional teams.
Excellent strategic thinking, communication, presentation and stakeholder-management skills.
Ability to operate independently, influence senior decision-makers and manage complex regulatory challenges.

Candidate Profile

The ideal candidate will be a confident, commercially aware regulatory leader who can combine strategic oversight with hands-on programme leadership. They will be comfortable navigating ambiguity, influencing stakeholders at all levels and aligning global and regional teams around a clear regulatory direction.

We are particularly interested in candidates who have operated at a senior level within a global pharmaceutical company and can demonstrate ownership of regulatory strategy, sound judgement in complex development environments and the ability to drive programmes towards key milestones.