Senior Regulatory Affairs Associate at Simple Pharma
, United Kingdom
Job Descrption
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.
Your CV has been submitted successfully.
Complete form below to directly Send your CV / Linkedin Profile to Senior Regulatory Affairs Associate at Simple Pharma.
@
You will receive all responses from employer on this email
Example: Application for the post of 'Accountant'
Example: Introduce your self and give purpose of your application
*All fields are mandatory.
Loading...
SIMPLE PHARMA 0 job found
No jobs found for this company. Try other companies.