Senior Regulatory Affairs Associate
| Posting date: | 03 September 2025 |
|---|---|
| Hours: | Full time |
| Closing date: | 10 September 2025 |
| Location: | Cambridge, Cambridgeshire, cb2 3ar |
| Remote working: | Hybrid - work remotely up to 2 days per week |
| Company: | SRG |
| Job type: | Permanent |
| Job reference: | BBBH167052_1756897760 |
Summary
Senior Regulatory Affairs Associate - Pharmaceutical
Artwork and Labelling
Cambridge
Permanent
£ Competitive
Role requirements:
With a core focus on the artwork and labelling aspect, this role offers a unique mix of creative and analytical duties which enable the business to meet its objectives around compliance, safety and maintaining up-to-date information for a portfolio of pharmaceutical products.
Role requirements:
- Taking the lead on labelling and artwork for the US portfolio of products - ensuring timely production, accurate presentation and compliance of regulatory information.
- Coordination of labelling changes - working with a variety of teams internally to identify risks and propose solutions.
- Preparation, review and approval of labelling documents, artwork files and print proofs.
- Contribute to and lead the preparation of ANDA/NDA submissions. Perform reference product PI checks and take ownership of the labelling database to ensure ongoing compliance.
- Lead the promotional material submission process to the FDA, prepare labelling for sections of the regulatory dossiers and submissions.
- Create, revise and finalise cartons, labels and leaflets for both new product launches and existing products which ensure that all standards pertaining to quality, regulatory and branding standards are met.
- Work with third parties to coordinate artwork that reflect the business branding elements.
- Use of Adobe Illustrator and InDesign tools to produce ready to print artwork of a high quality.
Your background:
- BSc in a Life Science subject, or equivalent.
- Approx 3-4 years of experience within regulatory affairs for Pharmaceutical with a proven focus on artwork and labelling.
- Good working knowledge of US-FDA regulations will be highly advantageous
- Good command of Adobe Illustrator or InDesign will be a benefit, or a similar package on another platform which produces regulatory-compliant artwork.
- Demonstrable ability to convey scientifically complex technical information with clarity and accuracy.
- Comfortable working to stringent deadlines, adaptable and agile in your approach to a dynamic environment with changing demands.
- Excellent written and verbal communication skills, capable of forming strong business relations through collaboration in cross-functional settings.
Does this look like the next move for you?
Do you have a proven regulatory affairs background from within the Pharmaceutical space, and want to bring your creative side into play too?
Please apply here or contact for more information or a confidential conversation about this exciting new role.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.