CMC Regulatory Specialist - Biologics
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-oriented 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.
The Role
Key Responsibilities:
- Plan and prepare strategies for post-approval activities, such as 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.
Requirements
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:
- Are 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.
- Have Regulatory Affairs experience, especially in technical/CMC/quality) within the pharmaceutical industry.
- Are experienced in writing CMC (technical) sections for regulatory documents (registration files or variations).
- Have experience in validation, Quality Assurance, or production, with experience preparing regulatory documents.
- Are experienced 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
How to Apply
If you would be interested in joining the team at G&L Scientific, please send your CV to talent@gandlscientific.com today.
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.
