At a Glance
- Tasks: Manage regulatory submissions and ensure compliance for marketed pharmaceutical products.
- Company: Join a leading pharmaceutical company dedicated to innovation and compliance.
- Benefits: Competitive salary, inclusive workplace, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on career development and inclusivity.
- Why this job: Make a real impact in the pharmaceutical industry while ensuring product safety and compliance.
- Qualifications: Bachelor’s degree in a relevant field and 3+ years of regulatory experience preferred.
The predicted salary is between 40000 - 50000 £ per year.
- JOB PURPOSE
- Plan, prepare, and submit regulatory variations for marketed products, including CMC changes, labeling updates, and maintenance of product licenses, ensuring ongoing regulatory compliance.
- Manage and execute assigned regulatory projects and activities requested by regional and global stakeholders, ensuring timely delivery and alignment with business objectives.
- Identify, assess, and address regulatory issues related to assigned products, providing regulatory guidance and coordinating with internal and external stakeholders as needed.
RESPONSIBILITIES
- Manage regulatory lifecycle activities for marketed products including shelf‑life extensions, CMC variations, manufacturing site transfers, GDS updates, renewals, and other post‑approval changes, ensuring timely submissions and approvals.
- Develop and execute short‑ and long‑term regulatory plans for assigned products, proactively tracking milestones and approvals to ensure continuous product supply and business continuity.
- Build and maintain effective relationships with regulatory authorities and internal stakeholders to facilitate regulatory activities and address emerging issues.
- Manage regulatory maintenance activities for existing products, including safety‑related updates, third‑party product support, Drug Identification Mark registrations, and other compliance requirements.
- Collaborate closely with Global Regulatory Affairs (GRA) and regional stakeholders to ensure alignment on regulatory requirements, submissions, and implementation strategies.
- Execute regional and global regulatory projects, ensuring timely completion of deliverables and effective cross‑functional collaboration.
- Monitor changes in local regulations and guidelines, assess regulatory impact, and develop appropriate compliance and implementation strategies.
- Provide regulatory expertise and strategic input to support business objectives while ensuring compliance with applicable regulatory requirements.
REQUIREMENTS
- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biology, or a related scientific discipline.
- Minimum 3+ years (Preferred) of Regulatory Affairs experience within the pharmaceutical industry, including end‑to‑end management of regulatory submissions and post‑approval changes.
- Strong knowledge of Korean regulatory requirements, registration procedures, and applicable guidelines.
- Experience in health authority interactions and regulatory review processes.
- Demonstrated ability to manage multiple projects and stakeholders effectively.
- Effective English communication skills with experience collaborating with global and regional teams.
- Strong analytical, planning, and problem‑solving capabilities with a proactive approach to regulatory compliance and risk management.
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants.
Contact
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Regulatory Affairs Specialist (Replacement of maternity leave, 2Y Contract) 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 Regulatory Affairs Specialist (Replacement of maternity leave, 2Y Contract)
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Gsk.
We think you need these skills to ace Regulatory Affairs Specialist (Replacement of maternity leave, 2Y Contract)
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Gsk.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Gsk. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Gsk
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Gsk.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Gsk achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
