At a Glance
- Tasks: Lead global CMC regulatory strategy for small molecule medicines and mentor colleagues.
- Company: Join GSK, a leader in science and technology, dedicated to advancing healthcare.
- Benefits: Visible impact, career growth, and the chance to unite science and talent.
- Other info: Collaborative environment with opportunities to influence senior leadership decisions.
- Why this job: Make a real difference in healthcare by shaping regulatory strategies.
- Qualifications: Degree in biological sciences or related field; extensive CMC regulatory experience required.
The predicted salary is between 80000 - 120000 £ per year.
You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for small molecule medicines. You will work closely with R&D, supply, quality and commercial colleagues to enable development, approval and uninterrupted supply. This role offers visible impact, career growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together.
Responsibilities
- Lead CMC regulatory strategy for investigational and early commercial small molecule medicines across global teams.
- Act as the CMC regulatory representative on cross‑functional project and leadership teams.
- Identify regulatory risks and propose clear mitigation plans to senior leadership.
- Mentor and develop regulatory colleagues and, where required, manage a small team.
- Direct project activities across multiple programmes and influence decisions at senior levels.
- Design practical solutions for complex regulatory challenges.
- Improve CMC regulatory processes and ensure regulatory positions support business needs while protecting patient supply.
Basic Qualifications
- Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
- Extensive CMC regulatory experience, including development and manufacturing knowledge.
- Proven experience preparing or contributing to global CMC submissions.
- Strong written and verbal communication skills for internal and external stakeholders.
- Ability to manage multiple projects and meet timelines.
- Experience working with cross‑functional teams (R&D, supply, quality, commercial).
Preferred Qualifications
- Advanced degree (MSc or PhD) in a relevant scientific discipline.
- Experience leading CMC regulatory teams or line management responsibility.
- Experience with lifecycle management and post‑approval regulatory activities.
- Practical experience engaging with global regulatory authorities and inspections.
- Track record of mentoring and developing junior colleagues.
Director, CMC Regulatory Affairs in Letchworth employer: Gsk
GSK is an exceptional employer that fosters a collaborative and innovative work culture, particularly for the Director of CMC Regulatory Affairs role. With a strong emphasis on career growth and mentorship, employees are empowered to lead impactful projects that unite science and technology in the fight against disease. Located in a dynamic environment, GSK offers unique opportunities to engage with global regulatory authorities and contribute to meaningful advancements in healthcare.
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We think this is how you could land Director, CMC Regulatory Affairs in Letchworth
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We think you need these skills to ace Director, CMC Regulatory Affairs in Letchworth
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.
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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
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✨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.
