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.