Description
Regulatory Affairs Manager - Global Biotech - Competitive salary + Benefits -England- Permanent Regulatory Position.This established Biotech is looking to grow their Regulatory team due to the amount of products they have coming through the pipeline. This Global Biotech has future plans to expand even more in the coming years. They are looking for a driven, committed and intelligent individual to join this rapidly expanding. The future prospects here are huge as due to the rapid future growth plans, the speed of your career progression will be determined by you.
The Regulatory Affairs Manager is responsible for:
- Leading European regulatory aspects of a product's development.
- Including strategic and project delivery.
- Representation to regulatory authorities.
- Internal team management and providing subject matter expertise globally.
- Be responsible for aspects of the regional strategy and execution of regulatory submissions:
- Contribute to the planning and preparation of the MAA and subsequent post authorisation variations and PRAC related activities.
- Act as the point of contact with European regulatory authorities, for single or multiple products, and planning relevant agency interactions.
- Global Regulatory, Development and Clinical Study Teams
- Collaborate closely with European regulatory country representatives on national issues.
- Applying for orphan designation for medicines for rare diseases.
- Review and approval of promotional and non- promotional materials.
What we're looking for
- Good understanding of the registration procedures inEuropefor MAA, variations, extensions, renewals, PIPs and clinical trials.
- Practical experience of centralised procedure for MAAs and CTA filings inEurope.
- Direct experience of interacting with EU regulatory authorities
- Bachelors degree, or equivalent combination of education and experience
Real Pharma are a world leader in placing regulatory affairs professional, with nearly 10 years experience in this market we are specialists who make sure we place the correct candidate in the correct environment.
For more information on this opportunity please contact Ben Moseley on or send you CV to b.moseley(a)realstaffing.com
To find out more about Real please visit www.realstaffing.com