Regulatory Affairs Manager
2 days ago
🔄 Hybrid – London
Description
• Accountable for managing the lifecycle of all assigned products • Preparing and reviewing documentation and supporting materials to be submitted to regulatory agencies including variations and renewal applications for medicinal products • Maintaining the product information and associated artworks and working closely with the supply teams to optimise changes • Prepare applications for marketing authorisations in new markets • Ensure compliance of promotional and non-promotional materials regarding the products • Manage regulatory change requests in compliance with our company’s procedures • Oversee operational activities to support regulatory compliance • Oversee the coordination of support agencies and in-country regulatory experts • Communicate with and own relationships with health authorities for relevant products • Deliver regulatory due diligence and transfer planning for products that Simple Pharma will manage • Provide regulatory leadership on integration project teams
Requirements
• 6-8 years of relevant professional experience within pharma or adjacent fields • Prior decision making responsibility for regulatory product lifecycle management • Problem-solver with high attention to detail • A can-do, no excuses attitude • Someone who can take ownership of tasks and drive them to completion • Humility and a desire to improve • A love of lean, well-oiled processes and operational efficiency • Motivation to join an early stage, high-growth business
Benefits
• Competitive salary £60-75k based on experience ensuring you're rewarded fairly. • Employee Stock Option. From day one, you’ll receive stock options making you a true partner in Simple Pharma’s success. • Comprehensive Private Medical Insurance: We've got you covered with top-tier health benefits. • Learning & Development: Enjoy an annual allowance for professional growth plus 2 days of paid study leave to support your development. • 25 days of holidays a year (plus bank holidays) and an option to buy 5 days per year. • Work from anywhere: Flexibility to work from abroad for the entire month of August. • August Holiday Perk: Use 7 holiday days and get an additional 3 days free. • Summer Hours: Enjoy 2pm Friday finishes during July and August. • Team Activities: We believe in the power of team bonding and regularly organise company-wide events and overseas company off-sites. • Dog-Friendly Office: You'll find a pup or 2 around our dog-friendly office. • Cycle to Work Scheme • High-Performance Team: Join an ambitious and dynamic team that’s passionate about excellence. • Continuous Investment: Benefit from ample training opportunities and resources. • Career Growth: Experience rapid professional and personal development opening doors to multiple career paths.
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