Regulatory Affairs Manager – 12m FTC

Who Are We

We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us.

We’re Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.

We are looking for a Regulatory Affairs Manager to join our UK/IE Regulatory Affairs team with a 12 months Fixed Term Contract. Overall, you will be submitting regulatory applications for the UK/IE licence portfolio (generics, branded, OTC…) and working with internal and external customers to ensure work is prioritised in accordance with business needs, ensuring high quality data and standards are used in support of all regulatory applications.

A day in life of a Regulatory Affairs Manager…

Main accountabilities:

• To manage post approval activities on a defined group of nationally approved products
• Review, compile and submit high quality regulatory submission packages to the UK MHRA, IE HPRA and other EU Regulatory agencies where applicable.
• To supervise, mentor and provide training for UK/IE Regulatory team members
• To work closely with manufacturing, QA, packaging testing, artwork origination and release sites, plus Medical and Pharmacovigilance departments, in order to support the preparation, compilation, review and submission of high quality regulatory documentation in accordance with UK/IE requirements, legislation, guidance and Teva procedures
• To work closely with EU RA Competence Centres in order to provide timely UK/IE specific documentation and/or information in support of EU new submissions and/or variations and renewals.
• To co-ordinate resource effectively to ensure that Regulatory approvals are secured in line with business timelines, and regulatory project support is provided
• To identify, initiate and prioritise areas for process improvement, and manage change as required
• To ensure that all activities fully comply with Departmental and Company SOPs & Work Instructions.
• To ensure that all internal tracking tools and electronic databases are maintained, accurate and complete.
• To represent UK/IE Regulatory Affairs in cross functional teams
• To understand and communicate complex issues to other Regulatory, Quality, Supply Chain, Product Management Medical, Pharmacovigilance, EPD and Senior Management colleagues
• To have excellent verbal and written communication skills
• Create opportunities for learning and development
• Other duties as required at the direction of Senior Manager Regulatory Affairs Officer and/or Director RA

Who we are looking for

Are you…

• Excellent oral and written communicator
• Able to work under pressure and to tight time deadlines
• Effective time and organisation manager
• Negotiator
• Analytical (data rational)
• Computer literate
• Flexible
• Action Oriented
• Problem solver

Do you have…

• Degree in life sciences/pharmacy or equivalent qualification(s) or significant experience in the Pharmaceutical Industry, including experience within EU or UK Regulatory Affairs
• Additional experience in R&D, Quality or Operations desirable.
• Good standard of technical knowledge – CMC experience desirable
• Coaching and supervisory experience
• Desirable to have UK, IE or other EU member state experience and knowledge of regulatory procedures
• Basic understanding of processes and departments within a pharmaceutical company

What do we offer you?

• 12 months Fixed Term Contract
• 25 days annual leave plus Bank Holidays
• Flexible benefits including health insurance, gymflex and cycle to work scheme
• Programme of Wellbeing initiatives including on-site Creative Rooms, Employee Assistance Programme, Wellbeing Champions