Your new company



Your new role

• Obtain and maintain generic and branded marketing authorisations for designated EU and non-EU territories (through internal and Third Party workstreams) to ensure on-time launches, continued supply and the compliance of all products.
• Ensure databases and systems are maintained in accordance with current SOPs to fulfil regulatory obligations.
• Advise Senior management of the status and progress of assigned projects to meet departmental and regional objectives and timelines; identifying potential problems or delays, and possible solutions, as they occur.
• Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities).
• Provide expertise and specialist knowledge to support the department. Provide mentoring and training to department in specialist areas, as required.
• Attend and contribute at Principal Registration Officer meetings; proactively raise issues and collaborate effectively to propose solutions. Ensure company/regulatory decisions are disseminated to junior team members.
• Support Regulatory through participation in or leadership of project teams and in the development of strategies for regional initiatives. Work alongside the Regulatory Management group to roll-out these initiatives.
• Provide mentoring, training and day-to-day support for junior team members.
• Support junior team members by reviewing data intended for submission and provide advice on deficiencies and issues, and in the preparation of regulatory strategies for new marketing authorisation applications / post-approval submissions.

What you'll need to succeed

BSc in Life sciences or higher-level qualifications.
Extensive and proven experience in EU Regulatory Affairs (SME – Subject Matter Expert)
Must have extensive experience of full lifecycle of existing or new product registrations including strategy/planning, registrations, monitoring, post marketing approvals, through to launching in accordance with EU regulations.
In-depth understanding of DCP / MRP processes, and able to give examples of estimating approval times and technical questions around variations and submissions.
Effective verbal and written communication skills.
Proven experience in managing large volume and fast paced product portfolios.
Flexible approach to enable prioritisation in line with company requirements.
Previous experience in mentoring junior team members of staff including.
Proven ability to effectively participate in working groups or project teams, and successfully collaborate with colleagues.
Computer literacy with Microsoft Office Suite and Documentum-based applications.

What you'll get in return

• Excellent career progression opportunities
• Work-life balance initiatives - 1 day a week in office
• Bonus scheme - 20%
• Health insurance
• Pension - 11%

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Raiyan Jawad now. raiyan.jawad@hays.com
If this job isn't quite right for you but you are looking for a new position, please contact Raiyan Jawad for a confidential discussion on your career.