Regional Regulatory Lead

CSL; Thatcham; Híbrido; GBP 90 000 - 130 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work model

On-site 3 days a week

Resumo da oferta

CSL Seqirus is seeking a portfolio-level regulatory strategist to shape regional strategy across APAC, LATAM, MEA, CIS and more. Based in Maidenhead with a hybrid 3-day on-site model, you will translate global strategy into regionally credible submissions and maintain essential health authority relationships.

You will lead on strategic submissions, lifecycle management, and regulatory risk assessment, partnering with Local Regulatory Responsible and Regulatory Partner colleagues to optimize

Qualificações

• Substantial experience in regulatory affairs within pharma or biotech.
• Experience with APAC, LATAM or comparable emerging markets.
• Ability to develop regional regulatory strategies aligned with global priorities.
• Strong knowledge of marketing applications, lifecycle management and PSURs across jurisdictions.
• Experience engaging with health authorities and coordinating cross-functional teams.

Responsabilidades

• Act as regional regulatory strategist for product portfolios across multiple regions.
• Develop and implement regional regulatory strategies aligned to global priorities.
• Contribute to Global Regulatory Strategy activities with cross-functional input.
• Provide strategic oversight of submissions and health authority responses.

Conhecimentos

Regulatory strategy

Stakeholder management

Cross-functional collaboration

Regulatory submissions

Formação académica

Biological or Medical Science or Pharmacy degree

Post-graduate qualification

Descrição da oferta de emprego

About the job

The Role This a portfolio-level regulatory strategy role covering regions with diverse regulatory requirements and market dynamics: APAC, LATAM, MEA, CIS, Adriatics and Partner Business Regions. Working with the Therapeutic Area Lead, you’ll set regional regulatory strategy for a defined product portfolio — not just chasing individual approvals, but shaping the pathway decisions, life cycle management, and health authority relationships that determine how well global strategy actually lands on the ground.

Location: Maidenhead/Hybrid, 3-days a week on-site

Why It Matters

A global regulatory strategy depends on strong regional insights across all markets. These regions do not follow the same dynamics as the US or EU — different evidentiary bars, different timelines, different risk calculus — and getting that wrong costs approval time and access. This role owns that judgment: turning global strategy into regionally credible submissions and pushing regional intelligence back up into global thinking before it becomes a problem rather than after.

What You’ll Be Responsible For

• You’ll act as the regional regulatory strategist for your product portfolio, balancing scientific rigor with the practical realities of dozens of different regulatory systems, while building the relationships — internal and external — that make timely approval possible.
• Develop and implement regional regulatory strategies aligned to global priorities, identifying the most efficient approval pathways with input from Local Regulatory Responsible (LRR) and Regulatory Partner Representative (RPR) colleagues
• Contribute to Global Regulatory Strategy activities, including planning and responding to complex scientific questions requiring product expertise and cross-functional input
• Provide strategic oversight of submissions — marketing applications, life cycle management, tender applications, and PSURs — anticipating regulatory risk before it becomes a delay
• Ensure high-quality submission documentation and health authority responses, delivered on schedule and to regional requirements
• Build and sustain strong working relationships with LRRs, RPRs, internal stakeholders, and regional health authorities themselves
• Stay current on international legislation and guidance relevant to CSL’s products and initiatives, including rare disease, orphan drug, toll manufacturing, and reliance pathway considerations

Experience Required

• Substantial experience in regulatory affairs within pharma or biotech, with direct exposure to APAC, LATAM, or comparable emerging-market regulatory environments
• A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification
• Demonstrated ability to develop and execute regional regulatory strategy in alignment with global product strategy
• Strong working knowledge of marketing application, life cycle management, and PSUR/reporting requirements across multiple jurisdictions
• Experience engaging directly with health authorities, with a track record of clear, credible communication that supports positive outcomes
• Comfort operating as a subject matter expert — assessing regulatory impact, identifying risk, and advising cross-functional teams accordingly
• A collaborative style suited to matrixed, multi-stakeholder environments, with the judgment to prioritize across a live portfolio
• English is mandatory, while additional language skill would be an asset (e.g. Arabic, French, Spanish, Russian)

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

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