Regulatory Affairs Senior Officer

This is an opportunity to be a part of a growing Regulatory Affairs group for an international pharmaceutical company. This role will involve managing new products and projects and will be part of a small, but experienced Regulatory Affairs team.

The Role: 

• Communicating with the MHRA at a strategic level 
• To respond to questions from regulatory authorities raised during technical reviews of submissions, variations and renewals 
• To ensure the company’s manufacturer (MIA) and wholesale dealer (WDL) licenses are maintained and up to date to allow importation and distribution of all of the company’s products 
• To support the regulatory department for eCTD submissions by either National, DCP or MRP procedures 
• To prepare submissions of license variations and renewals to strict deadlines 
• Leading key projects and working with key stakeholder across the business 
• Gaining an understanding of pharmacovigilance practices and procedures 
• Gaining exposure to the drug development process
   

• Strong & proven Regulatory Affairs Technology Transfer experience
• Excellent project management experience