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 Hampshire, Portsmouth 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 Hampshire, Portsmouth
✨Network like a Pro
In the pharmaceutical industry, getting your foot in the door can often come down to who you know. So, connect with professionals through platforms like LinkedIn or attend industry-specific conferences and trade shows. These are golden opportunities to meet decision-makers and to showcase your expertise.
✨Show Off Your Expertise
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✨Join Freelance Platforms
Don't underestimate the power of freelance platforms that focus on the pharmaceutical sector. Websites like Upwork or industry-specific job boards can help you find gigs that match your skill set. Remember to tailor your profile to highlight your relevant experiences and credentials.
✨Leverage Your Local Networks
Since the pharmaceutical industry often hinges on relationships, reaching out to local universities or research institutions can lead to lead generation. They might have collaborations or projects looking for freelance talent. Plus, don’t forget to connect with local pharma associations for gigs and networking opportunities!
We think you need these skills to ace Regulatory Affairs Consultant in Hampshire, Portsmouth
Some tips for your application 🫡
Showcase Your Expertise:In the pharmaceutical industry, it's super important to highlight your specific expertise. Make sure your CV or portfolio reflects your relevant experience—think clinical research, regulatory affairs, or drug development. Don’t forget to include any certifications or training you've completed that are particularly relevant to the role.
Include Case Studies or Project Samples:As a freelancer, your portfolio is your calling card. Include detailed case studies or samples from previous projects that highlight your contributions and results in the pharmaceutical sector. This could be anything from successful clinical trials you've worked on to regulatory submissions—use this to demonstrate your impact.
Articulate Your Availability and Rates:Freelance roles mean flexibility, so clarify your availability upfront. Be transparent about your rates too—this helps set the stage for negotiations. You can mention your preferred working hours and project lengths to align with what Apsida Life Science might be looking for.
Tailor Your Cover Letter:Your cover letter should connect the dots between your experience and the needs of Apsida Life Science. Use it to explain why you're interested in this freelance role specifically and how your background in the pharmaceutical industry can help solve their unique challenges. Let your personality shine through while remaining focused on professional achievements!
How to prepare for a job interview at Apsida Life Science
✨Show Off Your Expertise
Freelancing in the pharmaceutical industry means you'll want to highlight your specialised knowledge. Make sure to showcase your experience with regulatory processes or clinical trials, as these are crucial in this field. Share specific projects you've worked on to demonstrate your capability!
✨Know Your Tools and Tech
If you've worked with any industry-specific software, like LabArchives or Empower, get ready to discuss your experience with them. Being familiar with these tools will set you apart during the interview, as they’re often central to project success in pharmaceuticals. Don’t forget to mention how you’ve used data analysis in your previous roles – it’s key in this sector!
✨Bring Your Portfolio to Life
As a freelancer, your portfolio is your calling card. Prepare a compelling presentation that outlines your previous projects, focusing on results and methodologies. Highlight any case studies or publications to show your contributions to research or development – this can really grab the attention of Apsida Life Science.
✨Prepare for Scenario-Based Questions
Expect some scenario-based questions that might challenge your problem-solving skills in real-world contexts. Be ready to discuss how you would handle tight deadlines, regulatory hurdles, or unexpected findings in your projects. This will allow you to demonstrate not just your knowledge, but your practical abilities too!
