Regulatory Affairs/ RA Officer - Pharmaceutical
Salary: CIRCA £30,000
Our Client, a leading Pharmaceutical company are looking to recruit for an experienced Regulatory Office to work at their modern site in Preston; this role has come about through growth and acquisition, this is a fantastic time to join this company!
Role Purpose: To work with the Quality Manager to ensure compliance with regulations (UK and EU)
- Management and maintenance of the company's Manufacturing and Wholesale Dealers Authorisations in addition to the portfolio of authorised products.
- Writing of product dossiers in the eCTD format
- Attend external meetings, if required and relevant, with HFMA, BHMA, MHRA, FSA and act as central point for legislation and regulatory affairs and report up-to-date information on current and proposed legislation to the Senior Management Team and relevant departments
- Communicate with regulatory bodies (MHRA, Food Standards Agency, Trading Standards) when required ensuring the company is compliant with any requirements or requests
- Responsibility for VMS product notifications in Ireland
- Undertake Cosmetic Product Registrations where applicable
- Facilitate product registrations in export markets by:
- providing product documentation as and when required e.g TSE/BSE Statements, Supply Chain Maps, Certificates of Formulation and Certificates of Analysis.
- Liaising with the customer care export team
- Undertake Vegan Society Registrations of applicable Clients products
- Participate in regulatory inspections by the competent authority and customers
- Develop and write SOP's when required
- Support the Quality Manager in ensuring new and amended label text and advertising material is legal and raise and areas of concern, with the Senior Leadership Team accordingly
- Periodic review of the company website and product literature ensuring material is legal and raise and areas of concern, with the Senior Leadership Team accordingly
- Provide regulatory requirements and timelines on NPD projects e.g confirmation on the legal status of ingredients and applicable permitted limits.
- Ensure product formulas and finished products are designed to meet label claim including NPD and if there are any areas of concern liaise with Senior Leadership Team to consider whether to take action to change formulation and/or label.
- Attend monthly and weekly meetings as required eg Quality Council, Export meeting, NPD Meeting, Reformulations Meeting
- Work closely with all staff on site and especially production staff to ensure a good quality culture and openness
- Work closely with the wider regulatory affiliates ensuring professional service and where possible aligning processes and approaches.
- Responsible for the health and safety within the Quality Department ensuring safe systems of work are properly assigned, accepted and understood by all personnel.
- Will hold a Degree in a relevant Scientific discipline
- Will have worked in an RA role previously within a Pharmaceutical/ MHRA governed industry
- Have experience working to UK and UK regulations and submissions
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