Regulatory Affairs Support Administrator (Medical)

at  Chanelle Pharma

Loughrea
This is an opportunity to be part of a dynamic team within the 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 into the Medical Regulatory Affairs Manager, assist in the process of development of new products, attaining and maintaining Product Licences/ Marketing authorisation and assist in-house pharmacovigilance activities for the Medical Regulatory Affairs Department.

QUALIFICATIONS:

• Scientific qualification and background -preferably B.Sc. or equivalent.
• Experience in a regulatory/R&D environment preferably with experience in generic pharmaceutical applications.
• Good computer skills in MS Office preferably to ECOL level.
  Knowledge of EU GMP, regulatory and pharmacovigilance guidelines and advantage.

• Organise availability of documents/reports/dossiers in required formats for external parties’ due diligence and/or submissions
• Prepare, maintain, and file Product literature
• Prepare administrative sections of Regulatory dossiers
• Organise administrative support with external providers for applications/submissions.
• Order literature references / external documents and maintain database / indexes.
• Request of documents (CPP’s, Power of Attorney, legalization of documents)
• Request and coordinate delivery of documents/samples, fees for the team
• Manage incoming and outgoing documents via post, e-mail, in-person, or courier for regulatory affairs and Pharmacovigilance / Adverse Action Reports.
• Manage communication of pharmacovigilance activities in line with GVP and in-house requirements.
• Prepare regulatory reports and communications as required
• Manage team stationery supplies, manage post, couriers etc. on behalf the of regulatory / pharmacovigilance team.
• Maintain filing systems, indexes, and databases for the regulatory and pharmacovigilance team.
• Maintain, process invoices, and monitor spend v’s the department budget & maintain an overview of invoices/.
• Maintaining training records and trackers
• Manage invoice recharges for the regulatory / pharmacovigilance team
• Lead team in improvements and efficiencies
• Support team with day-to-day administrative and organisational activities