Regulatory Affairs Support Administrator

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 / Pharmacovigilance function, working closely with the other relevant functions within the business. 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.

 

KEY RESPONSIBILITIES:

• 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.
• Assist in preparing department budgets & maintain an overview of invoices/spend.
• Manage invoice recharges for the regulatory / pharmacovigilance team.
• Lead team in improvements and efficiencies.
• Provide regular updates on the regulatory status of applications.
• Support team with day-to-day administrative and organisational activities.

COMPETENCIES:
• Possess strong verbal and written communication skills with excellent attention to detail. Proficiency in Microsoft Office, PowerPoint, Excel, MS PowerPoint, and MS Outlook.
• Be detail and results-oriented, with an ability to multi-task and work in a dynamic, fast-paced environment.
• Work well under pressure, have excellent organizational abilities, set and meet deadlines, be able to handle several priorities in a day; be dependable, adaptable, creative, and self-motivated.
• Excellent interpersonal skills required.
The above is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required.

QUALIFICATIONS:
• 2 years+ experience in an administrative role,
• Pharmaceutical/healthcare experience would be an advantage.
• Excellent written and communication skills essential.
• Experience in providing administrative support to a busy team
• Administration qualification (preferable but not essential)
• Multinational experience (preferable but not essential)

Regulatory Affairs Support Administrator

Galway