Senior Regulatory Affairs Associate
- Cambridge
- Permanent
- Full-time
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- 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.
- 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.