Regulatory Affairs Administrator – Sanofi Consumer Healthcare
Based Reading, Berkshire
About the Opportunity:
We are offering you an opportunity to join Sanofi to provide a comprehensive administrative service to the Regulatory Affairs team to ensure the efficient running of the department in line with the company’s plans and goals.
About Sanofi Business Unit:
Sanofi displays a large portfolio of OTC medicines including leading brands like Buscopan, Dulcolax, Opticrom and Dioralyte. We are a dedicated team driven to improve the self-care treatments available to the public. We are a fast paced team of 30 plus, and have strong values – high integrity and work ethic, respect and teamwork as well as courage and dare to risk approach - which we live and breathe every day. We are looking for a like-minded individual who will help grow the different brands using new and initiatives ideas.
· Provide efficient and comprehensive support to the Regulatory Affairs team in order to ensure the smooth and efficient running of the Department. In conjunction with the Regulatory Affairs Managers, organise and prioritise workload to ensure the smooth running of the team in order to meet company deadlines and KPIs. Provide administrative support to the Regulatory team
· Maintain departmental and corporate databases, including SHARE, LOL, eMC and the Electronic Document Management System (EDMS) according to department SOPs to ensure accurate and comprehensive records
· Maintain off-site archiving system for the Regulatory department
· Generate and organise the dissemination of submission and approval information by means of the Approval Notification System. Update department systems and, when necessary, file in accordance with department procedures
· Arrange and co-ordinate meetings, travel and itineraries for team members
· Receive incoming telephone calls, take messages and/or deal with queries as appropriate. Distribute mail within the department to ensure it reaches its destination promptly. In the absence of members of staff, ensure that urgent post/email is redirected to an appropriate deputy
· If required, support the team, by assisting with the preparation of documentation and correspondence to obtain and maintain regulatory approval for marketing authorisations. This may include assisting in the drafting of applications for new marketing authorisations, variations and renewals, and preparing support documentation, based on initial instruction from regulatory personnel. As required, be responsible for compiling and submitting documentation to Regulatory Authorities in the UK, ensuring a high standard of presentation. Organise payment of fees and appropriate delivery of documentation
· Take responsibility for the export certification process, as required. Respond promptly to requests for Export certification. Prepare and submit applications to MHRA and instruct external companies (e.g. CDN) to achieve legalization etc. as required. Organize review of applications by Officers if necessary. Develop a good understanding of MHRA and other guidance on completion of the WHO CPP application form covering Certificate of Pharmaceutical Product, GMP Certificates, and Power of Attorney to ensure that applications are in line with current requirements and that customer needs and timelines are met. Keep up-to-date with developments in the guidance. Maintain appropriate filing systems for Export activities. Effectively liaise with the export sections of the MHRA, external companies involved in the process (e.g. CDN) and relevant company personnel
To excel in this role you will need to have:
· A well-qualified administrator with demonstrable experience, some of which should have been at senior level and trained in Microsoft Office packages
· Consumer Health, FMCG, Lifescience or Multi-National company background
· Accuracy, attention to detail and excellent presentation of work are essential, as is a mature and responsible outlook
· The ability to priorities work and cope under pressure is required
· The individual should also be conscientious, assertive and have a sense of confidentiality
· Good written and oral communication skills and organisational and interpersonal skills are essential
· A basic familiarity with Electronic Document Management Systems would be an advantage
· A basic familiarity with medical terminology would be an advantage
What Sanofi can offer you:
· We offer a generous package including flexible benefits and are committed to helping you have a healthy work-life balance throughout your career with us.
· We have highly subsidised restaurant with free tea and coffee.
· This is a full-time role based in Reading, Thames Valley Park. We support flexible working.
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and integrity.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.