At a Glance
- Tasks: Lead global CMC regulatory strategy for innovative biological products and collaborate with cross-functional teams.
- Company: Join GSK, a global biopharma leader committed to improving health for 2.5 billion people.
- Benefits: Enjoy competitive salary, bonuses, health benefits, and flexible hybrid working options.
- Other info: Dynamic environment with opportunities for professional growth and mentorship.
- Why this job: Make a real impact in healthcare by uniting science, technology, and talent.
- Qualifications: Degree in biological sciences or related field; extensive CMC regulatory experience required.
The predicted salary is between 100000 - 160000 £ per year.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.
You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products. You will work across R&D, supply, quality and commercial teams to enable development, approval and uninterrupted supply. We value clear decision makers who build strong partnerships, solve problems with practical solutions, and support the growth of colleagues. This role offers visible impact, professional 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 biological products across global teams.
- Understand, interpret and advise on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biological products, to expedite submission, review and approval of global CMC applications.
- Serve as a key strategic partner representing Global CMC Regulatory on cross-functional networks and matrix teams, advising R&D, supply, clinical trial supply, quality and commercial stakeholders.
- Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place to avoid clinical holds and protect supply.
- Identify regulatory risks and propose clear mitigation plans to senior leadership.
- Support major inspections and quality incidents by producing regulatory strategy and managing regulatory interactions.
- Mentor and develop regulatory colleagues, act as an individual contributor or may have direct line management responsibilities as per business needs.
- Ensure all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
- Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
- Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing requirements.
- 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.
- Experience with cell and gene therapies, therapeutic proteins or other complex biologics.
- Demonstrated success leading major inspections or regulatory interactions.
- Practical experience with global regulatory frameworks and agency engagement.
- Strong written and verbal communication skills for interacting with internal stakeholders and regulatory authorities.
- Ability to manage multiple projects, set priorities and meet timelines.
This role can be based in the United Kingdom (Ware, Stevenage or HQ), United States (UP or Waltham), Belgium (Wavre), Italy (Siena) or Switzerland (Zug). The position is offered as a hybrid role with a balance of on-site and remote working. Specific on-site days will be agreed with your manager to support team collaboration and stakeholder engagement.
We would welcome your application. Please include a short cover letter or summary that explains how your experience fits this role and why you are interested. We are committed to inclusion and will consider reasonable adjustments to support you during the application process.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
Director, CMC Regulatory Affairs in Ware employer: Gsk
GSK is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration in the biopharmaceutical sector. With a commitment to professional growth, employees benefit from mentorship opportunities and a hybrid working model that fosters flexibility and work-life balance. Located in vibrant areas such as Hertfordshire, GSK provides a supportive environment where individuals can thrive while making a meaningful impact on global health.
StudySmarter Expert Advice🤫
We think this is how you could land Director, CMC Regulatory Affairs in Ware
✨Tip Number 1
Network like a pro! Reach out to folks in your industry on LinkedIn or at events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching GSK’s latest projects and values. Show us you’re not just interested in the role, but also in how you can contribute to our mission of impacting health globally.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the Director, CMC Regulatory Affairs role. We want to hear how you can lead and innovate in regulatory strategy.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team.
We think you need these skills to ace Director, CMC Regulatory Affairs in Ware
Some tips for your application 🫡
Tailor Your Cover Letter:Make sure to customise your cover letter for the Director, CMC Regulatory Affairs role. Highlight your relevant experience and how it aligns with GSK's mission to impact patient health. We want to see your passion for the role!
Showcase Your Expertise:In your application, emphasise your extensive CMC regulatory experience in biopharmaceuticals. Mention specific projects or achievements that demonstrate your ability to lead and innovate in this field. We love seeing concrete examples!
Be Clear and Concise:When writing your application, keep it clear and to the point. Use straightforward language to convey your qualifications and avoid jargon. We appreciate a well-structured application that’s easy to read!
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Gsk
✨Know Your CMC Inside Out
Make sure you have a solid grasp of Chemistry, Manufacturing and Controls (CMC) regulations. Brush up on the latest guidelines and be ready to discuss how they apply to complex biological products. This will show your expertise and readiness to lead in this area.
✨Showcase Your Leadership Skills
Prepare examples that highlight your experience in leading teams and managing projects. GSK values clear decision-makers who can build strong partnerships, so be ready to share how you've successfully navigated cross-functional networks and influenced stakeholders.
✨Be Ready for Problem-Solving Scenarios
Expect questions that assess your problem-solving abilities. Think of specific challenges you've faced in regulatory affairs and how you approached them. Demonstrating your strategic thinking and risk mitigation skills will resonate well with the interviewers.
✨Engage with Their Mission
Familiarise yourself with GSK's mission to impact the health of 2.5 billion people. Be prepared to discuss how your background aligns with their goals and how you can contribute to their ambitious plans. Showing genuine interest in their mission can set you apart from other candidates.
