At a Glance
- Tasks: Provide regulatory support and develop documentation for life-saving bioprocess products.
- Company: Cytiva, a leading company in life sciences and biotechnology.
- Benefits: Competitive salary, career growth, and a culture of belonging.
- Other info: Join a dynamic team dedicated to transforming science into impactful solutions.
- Why this job: Make a real difference in human health while working with innovative teams.
- Qualifications: Bachelor's degree and 5-10 years in Quality Assurance or Regulatory roles.
The predicted salary is between 60000 - 80000 £ per year.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.
Responsibilities
- Provide regulatory support to Product Managers, Regions and customers by delivering quality documents and regulatory support in response to requests for quality, regulatory and technical information.
- Build and maintain knowledge of customers’ regulatory requirements related to the bioprocess business.
- Develop and update regulatory support documentation for products in customers’ regulated environments.
- Perform investigations and prepare and deliver statements and certificates.
- Participate in creating and updating guidelines and steering documents.
- Act as regulatory support expert and discussion partner to R&D, QA, Product Management and other functions and regions.
- Participate in project teams as regulatory support expert.
- Respond to regulatory-based issues promptly, including investigations, preparations and delivery of certificates, and use of internal/external databases.
- File and maintain complete documentation of questions and answers in databases; prepare, update and review regulatory support documentation (e.g., RSF, VG, VSF, CCN, statements, certificates) for new and existing products.
Requirements
- Bachelor of Science degree in Chemistry, Pharmacy or related field.
- 5–10 years of experience in Quality Assurance, Regulatory, or Product Management.
- Good understanding of GMP and regulatory requirements in the bioprocess industry.
- Excellent communication skills and fluency in English (written and spoken).
Nice to have
- Experience in large matrix organizations.
- Fluency in the language of the country of employment.
- Experience in customer communication.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
Locations
Senior Regulatory Support Manager in Hampshire, Portsmouth employer: Cytiva
Contact Detail:
Cytiva Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Support Manager in Hampshire, Portsmouth
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their products and how they impact lives. This will help you tailor your answers and show that you're genuinely interested in making a difference.
✨Tip Number 3
Practice your responses to common interview questions, but keep it natural. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your relevant experience in regulatory support.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about joining our mission to transform human health.
We think you need these skills to ace Senior Regulatory Support Manager in Hampshire, Portsmouth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that align with the Senior Regulatory Support Manager role. Highlight your experience in Quality Assurance and Regulatory, as well as any specific projects that showcase your understanding of GMP and regulatory requirements.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you're passionate about life sciences and how your background makes you a perfect fit for our team. Don’t forget to mention your communication skills and any relevant experiences that demonstrate your ability to support product managers and customers.
Showcase Your Problem-Solving Skills: In your application, give examples of how you've tackled regulatory challenges in the past. We love to see candidates who can think on their feet and provide solutions, so share any specific instances where you made a tangible impact in your previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you’ll find all the details you need about the position and our company culture there!
How to prepare for a job interview at Cytiva
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of GMP and regulatory requirements in the bioprocess industry. Be ready to discuss how your experience aligns with these regulations, as this will show that you understand the core of what Cytiva does.
✨Showcase Your Communication Skills
Since excellent communication is key for this role, prepare examples of how you've effectively communicated complex regulatory information in the past. Think about times when you had to explain technical details to non-experts—this will highlight your ability to be a discussion partner across teams.
✨Familiarise Yourself with Danaher’s System
Take some time to learn about the Danaher Business System. Understanding how it drives continuous improvement will not only impress your interviewers but also help you articulate how you can contribute to their mission of innovating for tangible impact.
✨Prepare for Scenario Questions
Expect scenario-based questions where you might need to demonstrate your problem-solving skills. Think of specific instances where you’ve handled regulatory issues or developed documentation under pressure, and be ready to walk them through your thought process.