At a Glance
- Tasks: Lead Clinical Trial Application submissions and ensure compliance with regulatory standards.
- Company: Join a leading pharmaceutical company focused on innovative therapies.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and career development.
- Why this job: Make a real impact in healthcare by accelerating access to new treatments.
- Qualifications: 9+ years in Regulatory Affairs with expertise in CTA submissions.
The predicted salary is between 60000 - 80000 £ per year.
Job Purpose
This role leads all CTA submission activities for new assets and pipeline products, ensuring timely and compliant regulatory submissions through effective stakeholder management and strategic planning to accelerate access to innovative therapies.
While the primary focus of this role is CTA submission leadership, the position also provides support to regulatory compliance and Quality Risk Management (QRM) activities within LOC RA, with opportunities to collaborate on governance and continuous improvement initiatives.
Key Responsibilities
- Regulatory Submission Management (CTA Expertise)
- Lead planning and execution of Clinical Trial Application (CTA) submissions in close collaboration with Clinical Operations and cross‑functional stakeholders.
- Oversee CTA submission timelines and ensure timely, high‑quality, and compliant submissions to the Health Authority.
- Review and approve CTA submission packages prepared by RA team members to ensure regulatory compliance and submission readiness.
- Independently prepare and manage CTA submissions for designated new assets or priority development programs, as required.
- Serve as the Local Subject Matter Expert (SME) for CTA regulations and submission processes, providing regulatory guidance and coaching to RA colleagues.
- Support effective interactions with the MFDS throughout CTA review and approval processes.
- Monitor changes in local clinical trial regulations, guidelines, and regulatory policies; assess potential impacts and communicate relevant updates to local, regional, and global stakeholders.
- Contribute to regulatory intelligence activities by providing strategic insights on emerging regulatory trends and requirements.
- Participate in external advocacy and policy‑shaping initiatives with regulatory authorities, industry associations, and relevant stakeholders, as appropriate.
- Drive continuous improvement of CTA submission processes and regulatory operational excellence.
- Support for Regulatory Compliance and QRM activities (as back‑up, scope to be aligned)
- Support regulatory compliance monitoring activities and contribute to KPI tracking and reporting.
- Contribute to the implementation and continuous improvement of the QRM framework within LOC RA.
- Assist in identifying and assessing regulatory and quality risks in collaboration with relevant stakeholders.
- Support deviation, RCA, and CAPA management activities as part of broader compliance processes.
- Contribute to inspection and audit readiness activities.
- Collaborate with local and global stakeholders to support alignment on compliance and quality requirements.
Requirements
- Minimum 9 years of experience in Regulatory Affairs, with substantial expertise in CTA submissions and a solid understanding of Regulatory Compliance, QMS, and/or QRM is desirable.
- Required to manage CTA submissions and to manage compliance systems, interpret audit findings, and drive CAPA effectiveness.
- Bachelor’s degree (Life Science/Pharmacy).
- Strong knowledge of local and global CTA regulations and guidelines, with hands‑on experience in preparing, reviewing, and submitting CTAs to the Ministry of Food and Drug Safety (MFDS).
- Strong knowledge of QMS, CAPA, risk management.
- Audit and inspection readiness experience.
- Good understanding of regulatory requirements and product lifecycle management.
- Strong stakeholder management, cross‑functional collaboration, and effective communication skills to engage with Health Authorities and global/regional stakeholders.
Skills
- Business Resilience
- Communication
- Digital Fluency
- Matrix Leadership
- Pharmaceutical Regulatory Compliance
- Stakeholder Management
EEO Statement
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. Contact for adjustment requests only; use standard contact channels for other enquiries.
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RA Manager employer: Gsk
GSK is an exceptional employer located in Greater London, offering a dynamic and inclusive work environment that fosters innovation and collaboration. As a Senior FinOps Product Manager, you will have the opportunity to drive impactful projects while benefiting from robust employee growth opportunities and a culture that values diverse perspectives. With a commitment to professional development and a focus on agile methodologies, GSK empowers its employees to thrive in their careers while contributing to meaningful advancements in cloud financial management.
StudySmarter Expert Advice🤫
We think this is how you could land RA Manager
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Gsk. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Gsk.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Gsk. 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 Gsk is looking for. A tailored application can really make you stand out!
We think you need these skills to ace RA Manager
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 Gsk!
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 Gsk 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 Gsk!
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 Gsk, 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 Gsk
✨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 Gsk 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 Gsk’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.
