Regional Regulatory Lead - Apac Latam Mea Cis Adriatics and Partner Business

**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/](https://www.csl.com/) and CSL Plasma at [https://www.cslplasma.com/](https://www.cslplasma.com/). **Our Benefits** For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](https://www.csl.com/careers/your-well-being). **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](https://www.csl.com/accessibility-statement). **Watch our ‘On the Front Line’ video to learn more about CSL Seqirus**