Quality Assurance and Regulatory Affairs ManagerMedical Devices Essex PermanentAttractive remuneration packageRole requirements:Maintaining, championing and developing the compliance and effectiveness of the Business Quality Management System...
The Regulatory Affairs Manager is responsible for all activity associated with affiliates across the Benelux region. Working as the responsible person for the distribution of Medicinal Products ensuring smooth integration of new products following launch with all associated post approval activities.
This would include Strategy planning, Communicating with internal Stakeholders and Health Authorities, ensuring Regulatory submissions are to the highest quality, compliant and in line with the business timelines and Global business functions
Manage the preparation of high quality documentation for all regulatory submissions, following current SOP's.Liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met in a compliant manner and to proactively communicate with regulatory authorities across Benelux in order to expedite approval of submissions.To anticipate and resolve complex regulatory issues independently.Manage submission strategy and plans across the Region.Write local SOP's related to compliance with GDP and compliance with Code of Practice forTo provide introductory training regarding local quality- or RA-steered SOPs applicable to staff entering the company.Act as deputy responsible person for GDP.To support or write applications for pricing and reimbursement in cooperation with the commercial units. To directly manage the budget, within agreed financial targets and to provide budget forecasts.Interact with industry trade associations and external consultants as necessary.Experience / Qualifications
Qualified Pharmacist or Physician
Extensive hands on Regulatory Affairs experience in Drug Development across the Benelux region.
Line Management experience
Strong Communication skills within English, French and Dutch languages
Role will require travel across EuropeIf you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.