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Global Change Facilitator – Regulatory CMC

Role overview

Qualifications

  • 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

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

Key facts

Other skills

  • Communication
  • Organizational Skills
  • Teamwork
  • Problem Solving
  • Adaptability
  • Curiosity

About the company

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BioPhorum

Company details

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Job description

Global Change Facilitator – Regulatory CMC

Location: Home-based (UK) with international travel


About BioPhorum

Established in 2004, BioPhorum is a leading business-to-business membership organisation that creates a unique environment for life sciences companies and executives to collaborate and accelerate progress across the sector.

With a subscription-based model, BioPhorum delivers 12 highly focused “Phorums” covering key areas including Drug Substance, Drug Development, Fill Finish, Technology Strategy, Supply Chain Resilience, Data & Digital, ATMPs, Quality, Regulatory, and Sustainability.

Today, more than 7,000 subject matter experts from over 150 organisations — including 18 of the world’s top 20 biopharma companies — collaborate through BioPhorum’s facilitated workstreams to solve industry-wide challenges and shape future best practices.

Following a period of strong growth, including new product launches and acquisitions, BioPhorum is entering an exciting new phase of expansion — and we are looking for a Global Change Facilitator to join our Regulatory CMC Phorum.


The Role

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.


Key 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

About the Regulatory CMC Phorum

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.


About You

You are a collaborative, intellectually curious professional who enjoys working in complex environments and bringing people together to solve meaningful industry challenges.


Essential Experience & Skills

  • 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

You Will Also Be

  • 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

Why Join BioPhorum?

  • Work at the forefront of global life sciences collaboration
  • Influence industry-wide regulatory and operational change
  • Collaborate with leading experts from across the global biopharma sector
  • Join a growing, forward-thinking organisation
  • Enjoy a flexible, remote-first working environment with international exposure

Apply Now

If you are passionate about driving collaboration and innovation within the life sciences industry and thrive in a high-impact, fast-paced environment, we would love to hear from you.

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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