Vet 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 Regulatory Affairs function. 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.

Reporting to the Regulatory Affairs Manager, you will ensure that marketing authorisations for the Chanelle Group are attained and maintained.

KEY RESPONSIBILITIES:

• Timely compilation and submission of regulatory documents: Export Applications (Medical and Veterinary):
Dossier submissions, responses (including scientific arguments), fees, samples, artwork, renewals, variations, notarised/legalised documents, pharmacovigilance.
• Communication on regular basis with supervisor/ relevant managers to give regular feedback on regulatory status of export applications.
• Assist R&D department in the development of formulations and manufacturing process for Chanelle developed products.
• Compilation of CTD regulatory dossiers Module 1 – 5 for EU National, MRP and DCP Marketing Authorisation (MA) applications.
• Review of process validation protocols and reports for inclusion in Module 3.
• Review of assay validation data and stability data to be included in Module 3.
• Review of Drug Master Files.
• Writing of Quality Overall Summaries for European MA’s.
• Responding to queries raised by the regulatory authorities or customers for new product licenses, renewals and variations.
• Preparation and submission of renewal applications for existing Marketing Authorisations.
• Preparation and submission of variation applications to existing Marketing Authorisations.
• Artwork review and approval.
• Transfer of data from Regulatory Department to QA and Production via Post.
• Licensing check lists.
• Responding to queries from other departments.
• Liaise with Joint-Venture companies outside EU in compiling dossiers, running Bioequivalence studies.
• Keep up to date with changes in global regulatory requirement.
• Ability to work on multiple projects simultaneously.

PHYSICAL DEMANDS: 

  • Health & Safety requirements (eg. Manual Handling Training)
  • Working with computers, paper files, etc – office work environment

 

 

WORK ENVIRONMENT: (eg. Office, Production)
Office

Vet Regulatory Affairs Executive

Galway