Senior Regulatory Affairs Associate

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