At a Glance
- Tasks: Support regulatory submissions for biotech products and collaborate with cross-functional teams.
- Company: Proclinical, a leading life sciences recruiter with a focus on exceptional talent.
- Benefits: Fully flexible remote work and opportunities for professional growth.
- Other info: Join a dynamic team with a collaborative culture and excellent career prospects.
- Why this job: Make a real impact in the biotech industry while working from anywhere.
- Qualifications: Degree in Life Sciences or Pharmacy; experience in regulatory affairs preferred.
The predicted salary is between 36000 - 60000 £ per year.
Are you a dedicated individual looking to put your expertise to work fully flexibly in a remote position? Proclinical is seeking a skilled Regulatory Consultant for a remote position!
Proclinical is seeking a Regulatory Consultant to support the preparation and coordination of regulatory submissions for biotechnology products, primarily within the EU-EEA regulatory framework. This role involves providing strategic input and hands-on execution of regulatory documents related to marketing authorization applications, variations, compliance submissions, and regulatory strategies across quality, clinical, and non-clinical domains.
Responsibilities:
- Prepare and coordinate initial invented name applications in line with EMA and national authority requirements.
- Lead and compile Module 1 components of Marketing Authorization Applications (MAAs), including drafting submission requests and supporting public disclosure or HTA interfaces.
- Develop and update Annex I (Summary of Product Characteristics) and Annex II (manufacturer information, GMP/GCP declarations).
- Draft and maintain SmPCs, ensuring alignment with clinical data, QRD templates, and regulatory standards.
- Coordinate Patient Information Leaflet (PIL) user testing, including protocol design, vendor management, and authority interactions.
- Support lifecycle management activities, including Maintenance of Certificate (MoC) submissions, post-approval variations, and change control justifications.
- Draft and submit Pediatric Investigation Plan (PIP) compliance applications and modifications.
- Advise cross-functional teams on regulatory requirements, timelines, and dossier expectations.
- Act as the regulatory point of contact for national competent authorities and EMA rapporteurs.
Key Skills and Requirements:
- Degree in Life Sciences, Pharmacy, or a related field; advanced degrees (e.g., PhD, PharmD) are a plus.
- Experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on EU regulatory procedures.
- Proven expertise in authoring and managing EU MAA documentation and lifecycle submissions.
- Previous history in Rare/Ophan disease is useful.
- Strong knowledge of EU regulatory guidelines, QRD templates, GxP principles, and procedural timelines.
- Proficiency in electronic submission systems (e.g., eCTD, CTIS, CESP) is preferred.
- Excellent written and verbal communication skills in English.
- High attention to detail, with the ability to manage multiple priorities and meet deadlines.
- Collaborative mindset with the ability to work independently and in cross-functional teams.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click \'Apply\' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you\'ve read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy.
Regulatory Consultant in England employer: Proclinical Staffing
Proclinical is an exceptional employer that values flexibility and work-life balance, offering a fully remote position for Regulatory Consultants. With a strong focus on employee growth and development, the company fosters a collaborative culture where your expertise in regulatory affairs can thrive, particularly within the dynamic biotechnology sector. Join us to make a meaningful impact while enjoying the unique advantages of working in a supportive environment that prioritises your professional journey.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Consultant in England
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We think you need these skills to ace Regulatory Consultant in England
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Proclinical Staffing!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Proclinical Staffing that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Proclinical Staffing!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Proclinical Staffing, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Proclinical Staffing
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Proclinical Staffing that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
