Global Change Facilitator – Regulatory CMC

BioPhorum

19h•Remote

About The Position

As a Global Change Facilitator within the Regulatory CMC Phorum, you will play a key role in enabling collaboration across the global biopharmaceutical industry. You will facilitate expert-led workstreams focused on Chemistry, Manufacturing and Controls (CMC) regulatory challenges, helping members share insights, align on best practices, and drive meaningful industry outcomes. Blending facilitation, project leadership, scientific understanding, and stakeholder engagement, you will create high-performing collaborative environments where complex regulatory and operational topics are translated into practical, impactful deliverables. This is a highly collaborative and fast-paced role requiring strong communication skills, organisational capability, adaptability, and a proactive approach. The regulatory landscape for CMC continues to evolve rapidly, driven by increasing product complexity, accelerated development timelines, global regulatory divergence, digitalisation, and emerging manufacturing technologies. In this role, you will help drive industry-wide collaboration and innovation by supporting initiatives focused on: Regulatory harmonisation and convergence, CMC lifecycle management and post-approval change management, Digital and data-enabled regulatory approaches, Global submission and regulatory strategy challenges, Emerging modalities and advanced manufacturing approaches, Inspection readiness and evolving regulatory expectations, Industry best practices for CMC development and compliance. You will work alongside senior leaders and subject matter experts from across the global biopharma ecosystem to help shape the future of Regulatory CMC.

Requirements

Degree-level education or equivalent experience within life sciences, pharmaceuticals, biotechnology, regulatory affairs, or related disciplines
Strong understanding of Regulatory CMC within the biopharmaceutical industry
Experience working within pharmaceutical, biotechnology, CDMO, consulting, or regulatory environments
Proven experience managing projects, initiatives, or change programmes
Strong facilitation and stakeholder management capability
Ability to synthesise complex technical and regulatory information into clear, actionable insights
Excellent organisational skills with the ability to manage multiple priorities and deliver against timelines
Comfortable operating within fast-paced, evolving environments
Confident working remotely and collaborating across global teams and cultures

Nice To Haves

A natural facilitator who enjoys enabling collaboration and productive discussion
A strong communicator who can influence and engage diverse stakeholder groups
A proactive and solutions-focused problem solver
A collaborative team player who values continuous improvement and feedback
Curious, adaptable, and motivated by industry impact

Responsibilities

Facilitate and lead a portfolio of Regulatory CMC workstreams, ensuring delivery of high-quality industry outputs and measurable member value
Create engaging and collaborative environments that encourage participation, knowledge-sharing, and industry alignment
Guide workstreams using structured project and change management approaches to deliver agreed objectives on time
Design and facilitate both virtual and in-person meetings, workshops, and events for senior industry stakeholders
Co-develop impactful deliverables including industry guidance, position papers, best practice frameworks, proof-of-concepts, and conference content
Monitor member engagement and proactively identify and resolve risks or barriers to progress
Maintain and optimise internal systems, reporting tools, and collaboration platforms
Capture and communicate value stories demonstrating the impact of industry collaboration
Feed member insights back into the organisation to support continuous improvement and future Phorum development