Medical Regulatory Affairs Executive

Galway

About Chanelle Pharma:

Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.

Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions. 

The Opportunity:

This is an opportunity to be part of a dynamic team within the Medical Regulatory Affairs Department. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers. This role reports into the Medical Regulatory Affairs Manager.

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
  • Critical review and regulatory approval of all reports and documents associated with EU / ROW Marketing Authorisation (MA) and all MA life-cycle applications.
  • Compilation of eCTD regulatory dossiers (Module 1 -5) for National and MRP/DCP Marketing Authorisation (MA) applications in an accurate and timely manner.
  • 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.
  • Organizing 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
  • Liaise with and respond to queries raised by the regulatory authorities in a timely and
  • 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.
  • Organizing 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

 

COMPETENCIES:

  • 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.
  • Escalates issues appropriately.
  • Good communication skills both written and orally.
  • Good technical knowledge of pharmaceutical products and processes

 

QUALIFICATIONS:

  • 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.

 

PHYSICAL DEMANDS:

  • Working with computers, paper files – office work enviroment 

 

WORK ENVIRONMENT:

  • Office

Medical Regulatory Affairs Executive

Reference No: J0236
Galway