Senior Regulatory Affairs Associate - Pharmaceutical
Do you have the right skills and experience for this role Read on to find out, and make your application.
Artwork and Labelling
Cambridge
Permanent
£ Competitive
Scope of role:
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 products with a proven focus on artwork and labelling.
* Good working knowledge of US-FDA regulations will be highly advantageous.
* Strong 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 bec.johnston@srgtalent.com for more information or a confidential conversation about this exciting new role.