Description
Medical Regulatory Affairs Office ManagerMy client a leading generic manufacturing pharmaceutical company based in Galway is looking to hire a medical regulatory affairs officer manager. They are an expanding organisation who have grown year on year and have continuously been expanding to their already vast range of products. They have one of the largest product portfolios in Europe.
Your role as regulatory affairs office manager would be to oversee & manage the process of dossier preparation, submission & maintenance of products and attaining and maintaining Product Licences / Marketing authorisation for the Group Companies. As the regulatory affairs office manager you will oversee and manage the communication of regulatory information from the company to the responsible Pharmacovigilance group for Pharmacovigilance/ EVMPD/Medical Information.
What the medical regulatory affairs office manager role will involve:
Preparation and compilation of CTD regulatory dossiers Module 1 - 5 for EU National and MRP/DCP Marketing Authorisation (MA) applications for key projects.
Review dossiers prepared by/or on behalf of the company prior to submission.
Review of protocols for Bioequivalence studies and Biostudy reports.
Auditing CRO's and monitoring of biostudies.
Set and manage timelines for timely response to queries raised by the regulatory authorities and Customers
Supporting outsourced activities such as pharmacovigilance, EVMPD, Medical Information, clinical and non-clinical work
Manage & oversee Artwork review and approval in Regulatory
Manage & oversee transfer of data from Regulatory Dept to NPI, QA, QC and Production.
Working with Qualified Persons Responsible for Pharmacovigilance (QPPV's) in line with pharmacovigilance procedures and practices to ensure the company's compliance with legislative requirements.
Maintain & update TMS for the Regulatory office. Update payroll with monthly payroll details.
Approval of Regulatory invoices for routine and annual Regulatory fees.
Manage & oversee recharging of costs to Customers on a timely basis.
Manage & maintain department measurements in line with Dept. KPI's.
Agree KPI's with RA Executives in the department (and carry out mid-year reviews with direct reports).
Prepare, maintain and manage department SOP's.
Manage & maintain training for regulatory Executives in the following areas - SOP, On the job and External training.
Preparation of Overhead and CP-MR- annual budgets for areas of responsibility.
Assist other departments in the company in Technical discussions.
Participate in conference calls with Customers (potential & current) as a regulatory to assist in regulatory advice.
Liaise with Customers and hold conference calls or face to face meetings to discuss regulatory strategies, deficiencies and any other customer query that may arise.
Experience required:
Scientific qualification and background preferably B.Sc qualified or equivalent.
Minimum 5+ years in a regulatory environment with experience in DCP/MRP and generic applications.
Experience in a busy problem solving environment with the ability to work to tight deadlines and on own initiative.
Strong attention to detail in generation of dossiers, protocols and reports.
Ability to work on multiple projects simultaneously.
Strong communication skills to ensure effective relationship with external and internal customers.
Detailed technical knowledge of products and processes.
Good IT skills and computer literate preferably to ECDL level.
An excellent salary of between €60,000 and €70,000 is on offer plus benefits. If you are interested in this role please contact me Adele Moran on for more information and for immediate consideration. Sthree UK is acting as an Employment Agency in relation to this vacancy.