Regulatory Affair Executive (Jordan)


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:

In this position you will be responsible for carrying out the functions of the Regulatory Affairs Executive ensuring that marketing authorizations for the Chanelle Group are attained and maintained.


  • Compilation of regulatory dossiers Part 1 – 4 for National (Export Applications) Marketing Authorization (MA) applications in a timely and accurate manner.
  • Communication on regular basis with supervisor/ relevant managers to give regular feedback on regulatory status of export applications.
  • Review of process validation protocols and reports for inclusion in Part 2.
  • Review of assay validation data and stability data to be included in Part 2.
  • Review of Drug Master Files
  • Writing of Quality Overall Summaries for National MA’s based on European Guidelines.
  • Responding to queries raised by the regulatory authorities or customers for new product licenses, renewals and variations in a timely and accurate manner.
  • Preparation and submission of renewal applications for existing Marketing Authorizations and doing follow up.
  • Preparation and submission of variation applications to existing Marketing Authorizations and doing follow up.
  • Artwork review and approval
  • Transfer of data from Regulatory Department to internal departments via Post Licensing check lists
  • Responding to queries from other departments.
  • Keep up to date with changes in global regulatory requirement.
  • Ability to work on multiple projects simultaneously.
  • Liaise with Regulatory Consultants and provide all the required to do local submissions.
  • Get the official documents notarized and legalized as per request.
  • Sending on/Arrange sending the required finished product samples, raw material standards and artwork samples (Demo) to customers as per request in companion with the related required documentations.
  • Keeping our internal records and databases updated.
  • Liaise with API suppliers and contract finished product manufacturers to get documentations specific for local submissions.
  • Suggest Trade Names for the local submissions in line with documentations we can offer (according to our Licences in Europe).
  • Proceed with Trademark Registrations in some countries according to the local regulations.
  • Search scientific databases to get recent scientific published articles as per request.
  • Organizing regulatory payments and the recharging of costs to customers in a timely manner.
  • Assist departments/affiliated companies/customers in technical queries and discussions.
  • Participate in conference calls to provide regulatory advice as required.
  • Advise Business Development Department employees upon request on feasibility of entering specific market from regulatory point of view.
  • Amend the submitted Periodic Safety Update Reports to EU authorities to pull out any confidential info, such as sales data, and submit within national MA applications.


  • Ability to build relationships and collaborate with others.
  • Ability to collaborate cross-functionally and across geographies.
  • Ability to work on multiple projects simultaneously, to tight deadlines and on own initiative.
  • Good attention to detail.
  • Good communication skills both written and orally.
  • Good technical knowledge of pharmaceutical products and processes.
  • Good customer focus.


  • 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.
  • Good computer skills in MS Office.
  • Knowledge of EU GMP, regulatory and pharmacovigilance guidelines.

Regulatory Affairs Executive (Jordan)

Reference No: J0533