At a Glance
- Tasks: Lead regional regulatory strategy for diverse markets, ensuring timely product approvals.
- Company: Global biotech firm focused on innovative health solutions.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with strong focus on career development.
- Why this job: Shape global strategies with regional insights and make a real impact in healthcare.
- Qualifications: Experience in regulatory affairs and a degree in Biological or Medical Science.
The predicted salary is between 63000 - 77000 £ per year.
This is 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
- 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).
Regional Regulatory Lead - APAC, LATAM, MEA, CIS, Adriatics and Partner Business in Maidenhead employer: CSL
As an Associate Director in Procurement Enablement at CSL, you will be part of a forward-thinking organisation that prioritises sustainability and governance while fostering a culture of continuous improvement and talent development. With a commitment to employee growth through the Global Procurement Academy and a collaborative work environment, CSL offers a unique opportunity to influence procurement practices on a global scale, making it an excellent employer for those seeking meaningful and impactful careers.
StudySmarter Expert Advice🤫
We think this is how you could land Regional Regulatory Lead - APAC, LATAM, MEA, CIS, Adriatics and Partner Business in Maidenhead
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like CSL. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like CSL.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like CSL. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what CSL is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regional Regulatory Lead - APAC, LATAM, MEA, CIS, Adriatics and Partner Business in Maidenhead
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at CSL!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show CSL that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at CSL!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At CSL, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at CSL
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at CSL that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with CSL’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
