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Pharma Regulatory Advisor

Technology 信息技術

Software Engineer

GCSE/Scottish Standard Grades A-Level Postgraduate or above 碩士或以上 Undergraduate or above 學士或以上 Intermediate apprenticeship 學徒

PSW Apprenticeship 學徒 華語工作 Contract 合同制 Full-Time 全職 Internship 實習 Part-Time 兼職

No

Beeston, Nottinghamshire, United Kingdom

Pharma Regulatory Advisor Grade: I Location: Nottingham, NG90 2PR Salary: £Competitive plus benefits, DOE BCM is part of Fareva, FAREVA is one of the world’s leading subcontractors in the Industrial and Household, Cosmetics and Pharmaceuticals fields We have a range of solutions to suit our customers’ needs and requirements – we manufacture iconic brands right from the client brief through to the completed product. We believe that whatever field you're in and at whatever level, you will be able to take ownership of your own development and progression and we will support you in this. We have a new and exciting opportunity for a Pharma Regulatory Advisor to join our Quality team. If you have an interest in working in a fast paced, commercial Pharma environment, and have relevant experience in a similar role, we would like to hear from you. The Regulatory Advisor is an integral part of the Pharma production unit, responsible for the maintenance of the Regulatory Compliance of the Pharma business unit. The role works collaboratively with the Pharma QA Manager, Head of Quality, business unit teams, other site teams, customers, authorities and inspection bodies. Responsible for driving continuous quality improvements and developing the business unit to be as self-sufficient as possible. Your working day will involve: Maintaining certification including MIA, controlled drug and pre-curser licenses Planning and facilitating regulatory inspections to ensure compliance. Liaising with and answering enquiries from regulators e.g., the MHRA and FDA Improving internal processes to reduce risk Coordinating with clients and team members to review, manage and maintain product compliance files and dossiers. Preparing and coordinating licence applications and variations to the MHRA Managing the requests for notarized and legalized documentation Answering client regulatory enquiries. Maintaining the regulatory database Providing regulatory advice and guidance Participating and contributing in preparation of departmental documentation Acting as regulatory contact for deviations, Change controls and relevant meetings. Regulatory watch over the Orange guide, ICH and Eudralex Coordinating the review of the Pharmacopeia updates. Assisting the Head of Quality and Quality Manager in any other required actions to support the smooth running of the Quality Department. Knowledge, Skills and Experience Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related). Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Credible and confident communicator (written and verbal) at all levels. Strategic thinker with the ability to influence at a senior level. Highly customer focused. Strong analytical and problem-solving ability. Hands-on approach, with a ‘can do’ attitude. Benefits We have a comprehensive benefits package, dependant on the role you are performing. In addition to a competitive salary, you may be entitled to the following; 25 Days Holiday plus Bank Holidays Option to purchase additional Holiday On-site parking with site security Opportunity to be part of an international company (Fareva) Onsite subsidised Café Cycle to Work Scheme Employee reward portal with huge range of discounts available Professional Subscriptions paid Defined contribution Pension scheme Life Assurance Employee Assistance Program