Regional Regulatory Lead
CSL · Emea
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.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus