At a Glance
- Tasks: Support Product Managers and customers with regulatory documentation for bioprocess products.
- Company: Join a leading company in the bioprocess industry focused on quality and customer satisfaction.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic team environment with opportunities to collaborate across functions.
- Why this job: Make a real impact by ensuring compliance and supporting innovative bioprocess solutions.
- 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.
As Regulatory Support Specialist you will support Product Managers, Regions, and customers by providing quality documents and regulatory support for bioprocess products. You will add value by ensuring 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 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 efficiently and promptly to customers’ regulatory issues, including necessary investigations, preparations and delivery of certificates, use of available internal and external 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.
Essential Requirements
- Bachelor of Science degree in Chemistry, Pharmacy or related field.
- Multiple years of experience from relevant 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.
Preferred Qualifications
- Experience working in large matrix organizations.
- Fluency in the language of the country of employment.
- Experience in customer communication.
For questions regarding the role please contact hiring manager Henrik Norberg, Senior Manager Customer Regulatory Support, henrik.norberg@cytiva.com.
Regulatory Support Specialist in Portsmouth employer: Cytiva
Cytiva is an exceptional employer for a Regulatory Support Specialist, offering a dynamic work environment that fosters collaboration and innovation in the bioprocess industry. With a strong commitment to employee development, we provide ample opportunities for growth and learning, alongside a supportive culture that prioritises customer satisfaction and regulatory excellence. Located in a vibrant area, our team enjoys a balance of professional challenges and personal fulfilment, making Cytiva a rewarding place to advance your career.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Support Specialist in Portsmouth
✨Get Involved in Local Research Communities
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Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
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Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Cytiva!
We think you need these skills to ace Regulatory Support Specialist in Portsmouth
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Cytiva that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Cytiva.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Cytiva does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Cytiva
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Cytiva. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Cytiva's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Cytiva. This shows your passion for the industry!
