Senior Regulatory Officer - Compliance

Compensation: Competitive total compensation.  

Opportunity Overview  

We have a newly created vacancy for three permanent Senior Regulatory Officers. You will work to manage new applications, variations and maintenance of International MA’s and build and develop International regulatory strategy and regulatory intelligence. You will be expected to lead by example in completing tasks and interacting with colleagues and stakeholders. You will also have the opportunity to take part in team mentoring and training.  

As Senior Regulatory Officer, you will be a flexible individual who is results and performance driven and has strong multi-tasking skills. An ability to develop productive relationships and cope with evolving deadlines would be highly beneficial. You will also possess good cultural awareness and sensitivity.  

This position will be located outside Dublin city center. 

Our client is a global specialty and branded pharmaceutical company, improving the health of patients across the world through their high quality and affordable medicines. 

Main Duties and Responsibilities:  

• Lead project teams or working groups as directed by management 
• Provide mentoring and support for new starters and less experienced team members  
• Representing RA Compliance at relevant meetings / telecons / WebExs 
• Lead by example to ensure tasks are completed in a timely and effective manner 
• Lead by example by displaying ownership and taking accountability for assigned activities 
• Proactive identification and reporting of potential issues to management 
• Ongoing process and systems assessment to enable continuous development 
• Develop / deliver training as appropriate 
• Contribute to the development and implementation of RA policies, processes, SOPs and other 
• Perform assigned work according to good regulatory practice and in compliance with current legislation and regulatory guidelines 

Person Specification  

Essential:  

·         Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree 

·         Minimum 3 years' experience in a regulatory affairs environment 

·         Relevant experience in, and general knowledge of, the pharmaceutical industry 

·         Knowledge of EU and other regions current registration and dossier requirements 

If you feel this description is something that fits your professional background and character, please apply now, or contact the team at Wentworth Life Sciences.