Medical Regulatory Affairs Executive

Medical Regulatory Affairs Executive- Remote Ireland- 12 month contract

Key Responsibilities:

• Compilation and submission of EU regulatory dossiers using National / MRP / CP/ DCP
  applications and submission / support ROW applications as required

• Critical review and regulatory approval of all reports and documents associated with EU /
  ROW Marketing Authorisation (MA) and all MA life-cycle applications.

• Advise and give guidance to R&D departments for the development regulatory required for
  dossier submissions in accordance with relevant requirements

• Compilation of eCTD regulatory dossiers (Module 1 -5) for National and MRP/DCP Marketing
  Authorisation (MA) applications in an accurate and timely manner.

• Liaise with and respond to queries raised by the regulatory authorities in a timely and
  accurate manner.

• Review dossiers/responses prepared by/or on behalf of the company prior to submission
  as required.

• Preparation and submission of renewal applications for existing MA’s.
• Preparation and submission of variation applications to existing MA’s.
• Review of in house supporting documentation to be included in a regulatory dossier.
• Review of Active Substance Master Files (ASMF).
• Review of protocols for Bioequivalence studies and Biostudy reports.
• Preparation of Product Specification Files (PSF’s).
• Auditing of CRO’s, monitoring of biostudies as required.
• Writing of Quality Overall Summaries.
• Artwork review and approval.
• Transfer of data from the Regulatory Department to internal departments.
• Work with the Qualified Persons Responsible for Pharmacovigilance (QPPV’s) in line with in house pharmacovigilance procedures and practices.
• Organising regulatory payments and the recharging of costs to customers in a timely
  manner.

• Address allocated department measurements in line with KPl’s.
• Assist departments/affiliated companies/customers in technical queries and discussions.
• Participate in conference calls to provide regulatory advice as required
• Establishes strong working relationships with others, building team rapport and creating
  a cohesive team environment.

• Strong Customer Service focus both internally and externally
• Ability to collaborate cross-functionally and across geographies.
• Ability to work on multiple projects simultaneously, to tight deadlines and on own initiative.
• Takes a methodical, systematic and structured approach to organising work.
• Good communication skills both written and orally.
• Good technical knowledge of pharmaceutical products and processes
• Escalates issues appropriately.

Education and Experience:

• Scientific qualification and background -preferably B.Sc. or equivalent.
• Minimum 3 -5 years in a regulatory/R&D environment preferably with experience in generic
  pharmaceutical applications.

• Strong Customer Service focus both internally and externally
• Excellent command of technical English (both written and spoken), with good verbal and
  written communication skills

• Strong computer skills in MS Office, MS Excel, Power Point etc.