At a Glance
- Tasks: Support customers with regulatory documents and ensure compliance in bioprocess products.
- Company: Join Cytiva, a leader in bioprocess technology with a focus on customer satisfaction.
- Benefits: Competitive salary, flexible working hours, and opportunities for professional growth.
- Other info: Collaborative environment with a strong emphasis on quality and customer service.
- Why this job: Make a real difference in the bioprocess industry while enhancing your regulatory expertise.
- Qualifications: Bachelor's degree in Chemistry or related field; experience in Quality Assurance or Regulatory roles.
The predicted salary is between 40000 - 50000 £ per year.
We're looking for a Regulatory Support Specialist to join Cytiva's Customer Regulatory Support (CRS) team at our site in the UK. The role supports Product Managers, Regions, and customers by providing quality documents and regulatory support in response to customers' requests for quality, regulatory, and technical-related information. As a member of the Customer Regulatory Support team, you will add value to bioprocess products and demonstrate a commitment to customer satisfaction.
Responsibilities
- Build and maintain knowledge of customers' regulatory requirements related to the bioprocess business at a high level.
- Develop and update regulatory support documentation for products in customers' regulated environments.
- Perform necessary investigations and prepare and deliver statements and certificates.
- Participate in creating and updating guidelines and steering documents.
- Act as a 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 efficiently and promptly to customers' regulatory-based issues, including investigations, preparations, and delivery of certificates, using available internal and external databases and other relevant databases.
- File and maintain complete documentation of questions and answers in databases; specify, prepare, update and review regulatory support documentation, including RSF, VG, VSF, CCN, statements, certificates, and other regulatory-related documentation for new and existing products.
Qualifications
- Bachelor of Science degree in Chemistry, Pharmacy, or related field.
- Multiple years of experience in positions within Quality Assurance, Regulatory, or Product Management.
- Good understanding of GMP and knowledge of regulatory requirements in the bioprocess industry.
- Excellent communication skills and fluency in English, both written and spoken.
- Organized, accurate, and target-oriented, with a strong focus on quality and customer service.
- Flexible, service-minded, and able to collaborate effectively across teams.
Preferred Qualifications
- Experience working in large matrix organizations.
- Fluency in the language of the country of employment.
- Experience in customer communication.
Regulatory Support Specialist in Portsmouth employer: Danaher Corporation
Cytiva is an exceptional employer that prioritises employee growth and development within a collaborative and innovative work culture. Located in the UK, our Customer Regulatory Support team offers a dynamic environment where you can enhance your expertise in regulatory affairs while contributing to meaningful bioprocess products that impact customer satisfaction. With a commitment to quality and a focus on teamwork, Cytiva provides unique opportunities for professional advancement and a supportive atmosphere that values your contributions.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Support Specialist in Portsmouth
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Cytiva or similar companies. A friendly chat can open doors and give you insights that might just land you an interview.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of regulatory requirements in the bioprocess industry. We want to see that you’re not just a fit on paper but also passionate about the role and ready to tackle real-world challenges.
✨Tip Number 3
Showcase your communication skills! During interviews, be clear and concise when discussing your experiences. Remember, as a Regulatory Support Specialist, you'll need to convey complex information simply and effectively.
✨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 genuinely interested in joining our team at Cytiva.
We think you need these skills to ace Regulatory Support Specialist in Portsmouth
Some tips for your application 🫡
Tailor Your CV:Make sure your CV speaks directly to the role of Regulatory Support Specialist. Highlight your experience in Quality Assurance and any relevant regulatory knowledge, as this will show us you understand what we're looking for.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory support and how your background makes you a perfect fit for our team. Don’t forget to mention your customer service skills!
Showcase Your Communication Skills:Since excellent communication is key for this role, make sure your application reflects that. Use clear, concise language and check for any typos or errors. We want to see your attention to detail right from the start!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates directly from us. Plus, it’s super easy!
How to prepare for a job interview at Danaher Corporation
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory requirements in the bioprocess industry. Familiarise yourself with GMP guidelines and be ready to discuss how they apply to the role. This will show that you're not just interested in the job, but that you understand the nuances of the field.
✨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 or resolve customer queries—these stories will highlight your skills.
✨Be Organised and Detail-Oriented
Demonstrate your organisational skills by discussing how you manage documentation and ensure accuracy in your work. You might want to mention specific tools or methods you use to keep track of regulatory documents and customer inquiries, as this will resonate well with the interviewers.
✨Prepare for Team Collaboration Questions
Expect questions about teamwork and collaboration, especially since you'll be working across various functions. Prepare examples of successful projects where you acted as a regulatory support expert, highlighting how you contributed to team goals and customer satisfaction.