Scientific Officer - Regulatory Affairs (Entry Level)
Scientific Officer – Regulatory Affairs (Entry Level)
Salary: £18,000 - £24,000 per annum + up to £3,000 discretionary Bonus
Location: Walsall, West Midlands
Working Hours: Monday – Friday 37.5hpw
We are a small but fast-growing healthcare company and due to expansion, we have a fantastic opening in our Regulatory Affairs team for a motivated individual who is looking to develop a career in regulatory affairs.
Ongoing training will be provided, giving you an excellent start to your career.
Office based, you will assist in the day to day running of the regulatory department whilst providing medical information to Healthcare Professionals, members of the public and other relevant stakeholders on pharmaceutical and medical device products.
Key responsibilities will include:
• Assisting in Regulatory Affairs activities including Pharmacovigilance (PV) and Licence Variations
• Answering medical information calls
• Conduct monthly / annual reviews of regulatory documents
• Review and write SOP’s, risk assessment forms, CAPA’s and change control documentation
• Quality compliance-assisting with the management of Quality Management Systems (QMS)
• Maintenance of SOP’s
• Ensuring compliance with EU PV legislation and internal SOP’s
• Proof reading documentation and label artwork
• Managing archiving systems
• Assist in preparation of new marketing authorisation applications
• Verifying suitability of customers and suppliers with respect to licensed medicines
• Provide assistance, information and documentation as required
• Assisting with the preparation of audits / inspections
• Degree in Life Sciences, Pharmacy, Chemistry or other relevant degree
• Excellent numerical and analytical skills
• Excellent attention to detail
• Strong communication, interpersonal and presentation skills
• Self-motivated, can multi-task and work to strict deadlines
• React quickly to situations whilst keeping calm under pressure
• Computer literate
We are seeking a passionate individual who has a real hunger to succeed and develop.
We seek people who innovate, collaborate, problem-solve and develop themselves.
The successful candidate will be a real people person, who has the confidence to quickly engage in conversation with a wide range of people, negotiate and influence situations to deliver great results.
At Fontus Health we keep people at the heart of everything we do and pride ourselves on our integrity and values.
We offer a competitive salary and a great benefits package which includes a discretionary bonus, enhanced annual leave, health cash plan and much more.
To apply: please forward your CV and covering letter to firstname.lastname@example.org
Full details can be found on our website at www.fontushealth.com/vacancies
Closing Date: Tuesday 27th November 2018
No agencies please