At a Glance
- Tasks: Develop regulatory strategies for post-approval vaccine products and support lifecycle management.
- Company: Join Apsida Life Science, a leader in clinical research and regulatory consulting.
- Benefits: Flexible remote work, competitive pay, and opportunities for professional growth.
- Other info: Collaborate with cross-functional teams in a dynamic and supportive environment.
- Why this job: Make a real difference in global health by supporting innovative vaccine therapies.
- Qualifications: Experience in Regulatory CMC, especially with vaccines and post-approval activities.
The predicted salary is between 63000 - 77000 £ per year.
Job Title
Regulatory CMC Vaccine Consultant
Location
Remote – Western EU / UK
Hours
Up to 150 hours per month
Company Overview
Apsida Life Science is partnering with a leading global clinical research organization that provides end-to-end clinical development and regulatory consulting services to pharmaceutical, biotechnology, and medical device companies.
With a strong global presence, the organization supports clients across the product lifecycle, delivering expertise in clinical research, regulatory affairs, pharmacovigilance, and market access to help bring innovative therapies to patients worldwide.
Key Responsibilities
- Develop and implement regulatory CMC strategies for lifecycle management (LCM) of post-approval vaccine products.
- Support post-approval regulatory activities, including: Post-approval variations, Annual Strain Updates (ASU), Responses to post-approval commitments and CMC change-related activities
- Provide regulatory CMC guidance for post-approval activities.
- Identify, assess, and communicate regulatory risks and potential impacts.
- Review CMC documents for submission readiness and ensure submissions conform to applicable Health Authority guidelines.
- Evaluate CMC change controls and provide regulatory assessment and recommendations.
- Contribute to regulatory briefing materials where required.
- Work closely with CMC, Regulatory Affairs, Quality, Manufacturing, and other cross functional teams.
- Support regulatory strategy and execution throughout the product lifecycle.
- Provide specific regulatory CMC support for the UK market.
Requirements
- Strong experience in Regulatory CMC, preferably within vaccines and/or biological products.
- Demonstrated experience supporting post-approval lifecycle management activities.
- Experience with post-approval variations and regulatory submissions.
- Experience with vaccines / Infectious Disease products.
- Experience supporting Annual Strain Updates (ASU) is highly desirable.
- Experience responding to post-approval commitments.
- Strong understanding of CMC regulatory requirements and Health Authority expectations.
- Experience evaluating CMC change controls from a regulatory perspective.
- Demonstrated ability to identify and communicate regulatory risks.
- Experience reviewing CMC documentation for submission readiness.
- Experience supporting the UK market is required.
- Strong knowledge of applicable global regulatory requirements and ICH guidelines.
- Excellent communication, problem-solving, and stakeholder-management skills.
- Ability to work independently and effectively within cross-functional teams.
If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science:
+44 744 134 1041
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry.
We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.
Locations
Regulatory Affairs Consultant in Cheshire, Warrington employer: Apsida Life Science
Apsida Life Science is an exceptional employer, offering a dynamic remote work environment that empowers Regulatory Affairs Consultants to thrive in their roles. With a strong focus on employee growth and development, the company fosters a collaborative culture where innovative ideas are encouraged, and meaningful contributions are recognised. Joining Apsida means being part of a dedicated team that is committed to making a real impact in the life sciences sector, all while enjoying the flexibility of working from anywhere in Western EU or the UK.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Consultant in Cheshire, Warrington
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We think you need these skills to ace Regulatory Affairs Consultant in Cheshire, Warrington
Some tips for your application 🫡
Show Off Your Lab Skills:When applying for a freelance gig in biotechnology, make sure to highlight any lab techniques or processes you're familiar with—think PCR, sequencing, or even cell culture! This industry is all about those hands-on skills, so don’t shy away from detailing your experience in your CV.
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Tailor Your Rates to the Industry:When applying for freelance positions, be upfront about your rates but also consider the industry standards. Research what others in the biotech space are charging and adjust your pricing accordingly, so you're competitive while still recognising your worth.
Make Your Availability Clear:As a freelancer, it's crucial to outline your availability in your application. Let Apsida Life Science know when you can start and how many hours per week you can dedicate to the project. Being clear about your schedule shows your organisational skills and commitment right from the get-go.
How to prepare for a job interview at Apsida Life Science
✨Show Off Your Lab Skills
For a freelance gig in biotechnology, it’s crucial to demonstrate your practical lab skills. Bring along a portfolio showcasing your past projects, experiments, or publications that highlight your proficiency with techniques like PCR, gel electrophoresis, or CRISPR. This tangible evidence can make you stand out in a field that highly values hands-on experience.
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Since you're applying for a freelance position, think of yourself as a consultant who can provide creative solutions to problems. Be prepared to pitch how your unique skill set can help Apsida Life Science solve specific challenges they face in their projects. This proactive approach will resonate well with potential clients and help you stand out.
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