CMC Regulatory Specialist - Biologics

Please note this position can be located in our offices in Barcelona 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.