Regulatory Affairs Executive

This is an opportunity to be part of a dynamic team within our regulatory 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.

In this role, you will report to the Regulatory Affairs Manager, assist in the process of developing new products, attaining and maintaining Product Licences / Marketing authorisation, support team members, oversee processes, and assist in-house pharmacovigilance activities for the Medical Regulatory Affairs Department.

Location: This role is eligible for Hybrid working after the completion of probationary period and can be based at our facility in Loughrea, Co Galway or onsite at our office in Amman, Jordan.

• Prepare, review, and compile eCTD regulatory dossiers (Module 1 – 5) for Export Marketing Authorisation (MA) applications in an accurate and timely manner.

• Liaise with and respond to queries raised by the regulatory authorities.

• Set and manage timelines for responding to authority/customer queries while ensuring timely and accurate preparation of responses.

• Review dossiers/responses prepared by/or on behalf of Chanelle Pharma prior to submission.

• Preparation, review, and submission of renewal applications for existing Export MAs.

• Preparation, review, and submission of variation applications to existing Export MAs.

• Review of in-house supporting documentation to be included in a regulatory dossier.

• Review of Active Substance Master Files (ASMFs).

• Write expert reports such as Quality Overall Summaries and bridging reports.

• Oversee/manage artwork review and regulatory approval process.

• Oversee/manage the transfer of data from the Regulatory Department to internal departments.

• Work with the Qualified Persons Responsible for Pharmacovigilance (QPPVs) in line with in-house pharmacovigilance procedures and practices to ensure Chanelle’s compliance with legislative requirements.

• Support outsourced activities such as pharmacovigilance, XEVMPD updates, Medical Information, distributors, Local responsible persons, and expert report generation as required.

• Review PSMF data, pharmacovigilance agreements, and signal detection reports as required.

• Oversee and organise regulatory payments and the recharging of costs to customers in a timely manner.

• Approve regulatory invoices and assist with budget generation as required.

• Oversee and maintain department measurements in line with KPIs.

• Preparation, review, and maintenance of department SOPs and work practice procedures.

• Support the development and training of team members.

• Assist departments/affiliated companies/customers in technical queries and discussions.

• Conduct presentations and lead meetings as required.

• Participate in conference calls to provide regulatory advice as required.

• Organisational skills, personal efficiency, time management skills, and the ability to prioritise competing demands are key communication skills.

• Ability to build relationships and collaborate with others is vital.

• Ability to support and motivate a team and collaborate cross-functionally and across geographies.

• Ability to work on multiple projects simultaneously, to tight deadlines and on own initiative.

• Team lead, Supervisory would be an advantage.

• Strong attention to detail.

• Fluency in English both written and orally is essential.

• Strong technical knowledge of pharmaceutical products and processes.

• Strong customer focus.

• Minimum B.Sc. in a scientific field: Pharmacy, Chemical Engineering, Chemistry, or equivalent.

• Minimum 2-5 years in a regulatory affairs/R&D department with experience in generic pharmaceutical applications essential.

• Strong computer skills in MS Office.

• Knowledge of EU GMP, FDA regulatory, and pharmacovigilance guidelines.