Senior Regulatory Affairs Consultants

Do you have the neccessary experience?

Due to the on going success of the Interim Management Department there is an ongoing need to recruit experienced Senior Regulatory Affairs professionals to join the team. With all the benefits of being a Unicus employee, you will have the added advantage of working with the most well respected R&D Pharmaceutical companies in the world

Duties

Due to the nature of Interim Management, duties for this role vary and are dependant upon client project requirements, in general though duties will include :

• Maintenance of Marketing Authorisations and licence variations and renewals
• Preparation of high quality, detailed regulatory documents using varied information sources
• Interacting with regulatory authorities on specific project / product issues when required
• Preparation and submission of regulatory applications (new submissions, renewals, variations, clinical trials etc.)
• Collecting data on regulatory intelligence
• Ensuring that project work proceeds according to agreed deadlines and maintaining status records
• Understanding and evaluating complex information
• Maintaining quality systems
• Liaising with relevant personnel within the working environment to obtain an understanding of client requirements
• Ability to manage large parts of a regulatory project.

Qualifications/knowledge required

• BSc Degree (or higher) in a scientific field and extensive experience in the Regulatory Affairs field
• Willingness to travel to client sites
• Strong technical expertise in a number of areas within the regulatory field
• Excellent written and verbal communication skills
• Flexible, adaptable and able to work autonomously
• Able to work to tight deadlines under pressure

Benefits

We offer a competitive salary and benefits package, dependent on skills and experience, along with a comprehensive training and development plan.