At a Glance
- Tasks: Lead and coordinate Clinical Trial Applications across Europe and beyond.
- Company: Join a globally recognised pharmaceutical organisation with strong financial stability.
- Benefits: Fully remote work, flexibility, and the chance to influence regulatory strategy.
- Other info: Collaborate with senior leadership and support global regulatory strategies.
- Why this job: Play a key role in innovative clinical development programmes and drive operational excellence.
- Qualifications: 7+ years in Regulatory Affairs with hands-on CTA experience in the EU and UK.
The predicted salary is between 63000 - 77000 £ per year.
We're partnering with a leading global pharmaceutical organisation to identify an experienced Senior Manager, CTA Regulatory Strategy to support the planning, execution, and oversight of Clinical Trial Applications across Europe and other international markets. This is an excellent opportunity to play a key role within a global regulatory team, partnering with Regulatory Leads and cross-functional stakeholders to drive successful clinical trial submissions while ensuring compliance with evolving regulatory requirements.
What you'll be doing:
- Support the development and execution of global regulatory strategies for Clinical Trial Applications
- Lead and coordinate CTA submission activities across the EU, UK, and other regions as required
- Act as the primary liaison between Regulatory Operations, Clinical teams, affiliates, and Health Authorities
- Provide strategic regulatory guidance on EU Clinical Trial Regulation (CTR) and UK Clinical Trial legislation
- Collaborate closely with Global Regulatory Leads to support regulatory planning and regulatory lifecycle activities
- Oversee CTA deliverables, timelines, quality, and compliance across assigned programmes
- Drive continuous improvement initiatives, process optimisation, and regulatory operational excellence
- Support regulatory intelligence activities and evaluate evolving regulatory requirements and guidance
- Provide functional oversight, coaching, and day-to-day support for external regulatory team members and vendor partners
- Represent Regulatory Operations in governance, project, and decision-making meetings
What we're looking for:
- Minimum 7 years of Regulatory Affairs experience within the pharmaceutical industry
- Recent hands-on experience managing Clinical Trial Applications within the EU and UK
- Strong knowledge of EU Clinical Trial Regulation (CTR) and UK Clinical Trial Regulations
- First-hand experience using CTIS, IRAS, and associated Health Authority submission portals
- Experience supporting global regulatory strategy and regulatory submission activities
- Ability to interpret and apply complex regulatory requirements across development programmes
- Experience working cross-functionally within global, matrixed environments
- Strong communication, stakeholder management, and influencing skills
- Experience working with electronic document management systems (Documentum preferred)
- Prior experience supervising deliverables, external vendors, consultants, or indirect reports is highly advantageous
Why this opportunity?
- Join a globally recognised pharmaceutical organisation with strong financial stability
- Take ownership of high-profile CTA programmes across Europe
- Work closely with senior global regulatory leadership
- Influence regulatory strategy and operational excellence initiatives
- Lead critical submissions supporting innovative clinical development programmes
- Fully remote opportunity with flexibility across the UK or Germany
Interested or know someone who could be a fit? Feel free to reach out directly or apply confidentially!
Sr. Manager, CTA Regulatory Strategy in Bolton employer: Meet Life Sciences
As a Market Access Consultant with our client, you will be part of a dynamic team that values innovation and collaboration in the evolving healthcare landscape. The company offers a supportive work culture with opportunities for professional growth, including mentoring junior team members and leading impactful projects. With competitive compensation, hybrid working options, and comprehensive benefits, this role provides a meaningful opportunity to contribute to the expansion of European Value & Access capabilities while enjoying a fulfilling work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Sr. Manager, CTA Regulatory Strategy in Bolton
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Meet Life Sciences. 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 Meet Life Sciences.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Meet Life Sciences. 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 Meet Life Sciences is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Sr. Manager, CTA Regulatory Strategy in Bolton
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 Meet Life Sciences!
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 Meet Life Sciences 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 Meet Life Sciences!
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 Meet Life Sciences, 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 Meet Life Sciences
✨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 Meet Life Sciences 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 Meet Life Sciences’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.
