Regulatory Affairs Manager Permanent GlasgowAre you an experienced Regulatory Affairs Manager looking for a new challenge?Do you have experience working within medical devices or a...
My client, a Global Pharmaceutical Company, has opened a new vacancy within their Regulatory team and are actively looking to recruit a Regulatory Affairs Senior Manager. The role will be based at my client's offices in Central London.
The Regulatory Affairs Snr Manager provides regulatory support and expertise on assigned programmes, and is responsible for specific pieces of moderately complex projects. In addition, the Regulatory Affairs Snr Manager reviews scientific documents intended for submission to regulatory authorities in the International Regions.
Assists with the planning and preparation of submissions to regulatory authorities, with minimal supervision
Independently solves problems of moderate complexity and scope, with limited supervision
Determines the best and most appropriate methods and procedures on new assignments independently
Applies knowledge of regulatory requirements to the review of scientific documentation and supporting country specific documents intended for submission to regulatory authorities
Analyses new regulations and guidelines and makes process improvement recommendations to group
Prepares and delivers effective presentations for department meetings
May represent Regulatory Affairs department on assigned project sub-teams and/or task forces, with supervision
Skills and Experience required:
BSc. Advanced scientific related degree preferred;
Experience in preparation and submission of documentation for Global agencies; such as CMPs/CPPs, MAAs, variations, PSURs including country specific requirements.
Demonstrates effective, self-sufficient communication skills, especially in peer-directed presentations
Displays sound project management skills
Exercises good judgment within defined procedures and practices to determine viable solutions
Demonstrates advanced knowledge and understanding of applicable regulations
Speaking a second European language is desirable.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.