Senior Regulatory Affairs Associate
Location
Fitzrovia, Greater London | United Kingdom
Job description
Senior Regulatory Affairs Associate
£42,000-50,000 plus benefits | Reporting to VP, Pharmaceutical Operations | UK office (Fitzrovia, London)
The Simple Pharma Group creates and develops pharmaceutical companies. Its portfolio of companies comprises Simple Pharma and Androlabs. Simple Pharma is the best home for proven pharma products and provides integrated, digitally enabled, end to end operations, distribution, and compliance services to pharma companies. Androlabs is the first pharma company to focus on keeping men healthy.
Some metrics about us: 30 team members, €10m+ of sales, 50% annual growth, 0.5m+ units shipped per month, 100+ wholesale customer sites in 20 countries. Team includes alumni of Oxford, INSEAD, McKinsey, Latham & Watkins, J&J.
We’re looking for a motivated and creative Senior Regulatory Affairs Associate who wishes to gain valuable hands-on experience leading across a variety of topics. You will be working closely with our VP, Director of Pharmaceutical Operations on various strategic projects and leading regulatory lifecycle activities for specific products/customers on a global scale.
What you will be doing
Regulatory Affairs
- Be the regulatory product owner for all assigned products, which entails:
- Prepare documentation and supporting materials to be submitted to regulatory agencies including variations and renewal applications for medicinal products, with minimal supervision
- Maintaining the product information and associated artworks, and working closely with the supply teams to optimise any changes
- Prepare MA applications in new ROW countries (for existing products)
- Ensure compliance of promotional and non-promotional materials regarding the products and therapeutic area
- Manage regulatory change requests in compliance with our company’s procedures and Quality Management System
- Oversee operational activities to support regulatory compliance
- Oversee the coordination of support agencies (e.g., regulatory publishing teams) and in-country regulatory experts.
- Communicate with health authorities when relevant
Support product acquisitions and transfers
- Support regulatory due diligence of potential acquisitions & transfers
- Regulatory lead on integration project teams to streamline the marketing authorisation transfer process and associated artwork changes
- Plan and structure new products’ regulatory agenda
Market access
- Support the launch of assigned products in new countries
- Prepare dossiers for price and reimbursement submissions
Infrastructure Creation
- Contribute to the development of the functional operating model, and the digitisation of the Simple Pharma service offering
- Identify gaps in our delivery model and onboard new support agencies where needed to deliver the company goals.
Requirements
What you’re bringing
- A Bachelor’s or Master’s degree in Chemistry / Pharmacology / other related STEM subject. Regulatory qualifications are a bonus.
- 2-4 years of relevant experience working in regulatory affairs for established medicinal products
- Willingness to roll up your sleeves and get involved in a wide range of topics
- Problem-solving, can-do attitude
- Team-oriented approach
- High attention to detail
- Fluency in English
Benefits
Benefits
- Competitive salary (£42 to £50k based on experience)
- Employee stock option award on joining
- Private health and dental insurance
- Work from anywhere for the month of August
- Use 7 get 3 free holiday days in August
- 2pm Friday finishes in July & August
- Regular team events
- A high performance, ambitious roster of colleagues
- Ample training and investment in the team
- The chance for rapid professional and personal development, and a springboard into several career paths
The Simple Pharma Group is a meritocracy - we hire based on people's skills, experiences and potential to contribute to our success.
Job tags
Salary
£42k - £50k per annum
