Regulatory Professional

Overview

Calling All Regulatory Rockstars – Join G&L Scientific in Belfast!

At G&L Scientific, we don’t just consult—we transform. We’re the behind-the-scenes heroes helping healthcare companies navigate the complex world of Regulatory Affairs and Quality Assurance. And guess what? We’re growing fast and looking for CMC-savvy Regulatory pros to join our vibrant Belfast team!

Why G&L?

• We tailor every solution like a bespoke suit—because one-size-fits-none.
• Our clients love us (seriously, they do).
• We work on biotech and pharma projects that span everything from development to approved products.

What’s in it for you?

• A front-row seat to exciting, diverse projects.
• A team that values your expertise and celebrates your wins.
• The chance to shape the future of healthcare—without the corporate snooze-fest.

If you’re a Regulatory Affairs professional who knows their CMC from their CTA and wants to work somewhere that’s as dynamic as you are, let’s talk.

Responsibilities

As a G&L consultant, you will be working with a variety of clients, and your duties may include the following:

• Developing submission strategies and planning for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
• Evaluating change controls and providing regulatory assessments to classify quality changes in production and quality control.
• Supporting client project teams in the preparation of the CMC sections of all submission content to facilitate approvals and continued compliance.
• Reviewing key study reports (e.g. process validation, stability studies, analytical method validation) to ensure regulatory compliance.
• Developing and maintaining high quality, realistic Chemistry, Manufacturing & Control (CMC) plans for products in development.
• CMC authoring of Module 2.3 and Module 3 sections of the CTD dossier.
• Maintaining a positive and productive liaison with internal and external contacts. This may include clients, regulatory agencies, and related institutions.
• Attending formal interactions (face-to-face meetings, teleconferences etc.) with clients, and possibly, government agencies. Building positive working relationships with clients.
• Identifying gaps and risks in the CMC plans and working with the team to proactively develop solutions which will increase efficiency and minimize timelines.
• Assisting in the development of assessments and strategic regulatory plans for client product development programs.
• Reviewing CMC sections of BLA submissions and preparing gap analysis detailing requirements for submission to different jurisdictions.
• Participating in project teams and advising other departments on CMC regulatory issues and strategies, including manufacturing, supply chain, quality control, quality assurance, and other regulatory and local entities.

What skills and experience do you need to apply for this position?

• A Life Science degree is a must
• Between 2 and 10 years working knowledge of CMC regulatory Affairs. If you have experience with Biologics or Biosimilars, even better
• Experience in authoring technical / CMC parts of regulatory documents
• Knowledge of Health Canada, FDA, EMA and International Conference on Harmonization practices, regulations and guidelines and implementation into regulatory filings; integration of CMC data into regulatory and quality documents.
• Ability to maintain a high level of accuracy and attention to detail
• Problem solving, judgment and decision-making skills to seek creative solutions to issues surrounding on-time, on-budget and high-quality project outcomes
• Excellent planning, organization, interpersonal, time and change management skills.
• Working knowledge of RIM Systems including Veeva Vault would be advantageous
• Proficiency in MS-Office applications including Microsoft Word, Excel and PowerPoint.

Our bright, spacious offices in Lanyon Place are more than just a workplace—they’re a hub of collaboration, creativity, and coffee-fueled brilliance. We embrace a hybrid work model, so you’ll only need to be on-site two days a week.

Whether you\\\’re brainstorming regulatory strategy or diving deep into CMC documentation, you\\\’ll have the flexibility to balance focus and freedom—plus a gorgeous office to come back to when you need that team energy!