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- Tasks: Join our team to guide clients through complex regulatory strategies for biological products.
- Company: G&L Scientific is a leading consultancy in healthcare, known for tailored regulatory solutions.
- Benefits: Enjoy flexible work with 2 days on-site and opportunities for global project involvement.
- Why this job: Perfect for those who thrive on challenges and enjoy client interaction in a dynamic environment.
- Qualifications: Strong understanding of CMC regulations and experience in regulatory affairs within the pharmaceutical industry.
- Other info: Fluency in English and a local language is required; familiarity with Veeva Vault is a plus.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Please note this position can be located in our offices in Barcelona, Belfast or London Paddington with 2 days on site.
G&L Scientific is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.
We now have an exciting opportunity for Regulatory professionals to provide expert guidance and support across a variety of biological products.
You’d be joining our international team of experienced Regulatory professionals who manage multiple global projects for a wide variety of clients – from giant pharma to niche biotechs. A day in the life of one of our consultants may be varied and unpredictable – this opportunity is ideal for someone who thrives on challenges, enjoys client interaction, and guiding client programs through complex regulatory strategies. The successful candidate will be completely solutions-orientated with well-developed client management and customer service skillsets.
About Us:
We are a leading consultancy firm with offices on three continents, and we are building our specialist team of consultants with knowledge of medical devices, diagnostics, and combination products. Our team works closely with a wide range of clients from start-ups to established companies, helping them navigate the complex regulatory landscape and bring innovative products to market. Our projects cover everything from cutting-edge medical devices to companion diagnostics and combination products.
What will be my key responsibilities?
- Plan and prepare strategies for post-approval activities like variations, renewals, market expansions, and annual reports.
- Evaluate change controls and provide regulatory insights on quality changes in production and quality control.
- Review study reports (like process validation, stability studies, analytical method validation) from quality control and production to ensure everything meets regulatory standards.
- Work with teams across manufacturing, supply chain, quality control, quality assurance, and other regulatory departments to coordinate submission preparation.
- Write or review submission content to make sure it aligns with regulatory requirements (for variations and health authority questions).
- Identify, escalate, and manage risks related to regulatory procedures and activities.
What do I need to have to be successful in this role?
- Strong understanding of CMC and post-approval regulatory requirements.
- Knowledge of regulatory processes, systems, and guidelines (like quality control, stability, process validation, and comparability studies).
- Excellent written and spoken English.
- Proficiency in a local language (depending on location: French, Italian, or German).
- Understanding of biological processes and qualification/validation principles.
You will be a great fit for this role if you:
- Good at managing your time to meet deadlines.
- Are a clear communicator, especially in a multicultural and multidisciplinary setting.
- Have strong writing and analytical skills, with a keen attention to detail.
- Creative, critical thinker.
- Are a team player who is flexible, well-organized, and accountable.
What Experience Do You Need?
- Experience in regulatory affairs (especially in technical/CMC/quality) within the pharmaceutical industry.
- Experience writing CMC (technical) sections for regulatory documents (registration files or variations).
- Experience in validation, Quality Assurance, or production, with experience preparing regulatory documents.
- Experience working with Biological products in mandatory for the role
Education & Other Requirements:
- University degree (preferably in Life Sciences) or equivalent experience.
- Proficient in Word, PowerPoint, Excel; familiarity with Veeva Vault is a plus.
- Fluent in English and depending on location, French, German, or Italian.
CMC Regulatory Specialist - Biologics employer: G&L Scientific
Contact Detail:
G&L Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CMC Regulatory Specialist - Biologics
✨Tip Number 1
Familiarise yourself with the latest CMC regulatory guidelines and standards specific to biologics. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with biological products. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends and challenges.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences that showcase your problem-solving skills and ability to manage complex regulatory processes. Highlighting your successes in similar roles can set you apart from other candidates.
✨Tip Number 4
Research G&L Scientific and understand their client base and projects. Tailoring your conversation during interviews to reflect how your skills align with their needs will show that you are genuinely interested in contributing to their team.
We think you need these skills to ace CMC Regulatory Specialist - Biologics
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, particularly in CMC and quality within the pharmaceutical industry. Emphasise any relevant projects you've worked on, especially those involving biological products.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the role and the company. Mention specific experiences that demonstrate your ability to manage regulatory processes and your strong communication skills in a multicultural environment.
Highlight Relevant Skills: In your application, clearly outline your proficiency in writing CMC sections for regulatory documents and your familiarity with regulatory processes. Include any language skills that are relevant to the position, such as French, German, or Italian.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Ensure there are no grammatical errors and that your writing is clear and concise, reflecting your attention to detail and strong writing skills.
How to prepare for a job interview at G&L Scientific
✨Showcase Your Regulatory Knowledge
Make sure to brush up on your understanding of CMC and post-approval regulatory requirements. Be prepared to discuss specific examples from your past experience that demonstrate your knowledge of regulatory processes, systems, and guidelines.
✨Demonstrate Client Management Skills
Since the role involves client interaction, think of instances where you've successfully managed client relationships. Highlight your customer service skills and how you've guided clients through complex regulatory strategies in previous roles.
✨Prepare for Technical Questions
Expect questions related to writing CMC sections for regulatory documents and your experience with biological products. Be ready to explain your approach to evaluating change controls and ensuring compliance with regulatory standards.
✨Emphasise Team Collaboration
This position requires working across various departments. Share examples of how you've effectively collaborated with teams in manufacturing, quality control, or other regulatory areas to achieve common goals and manage submission preparations.
