Senior Regulatory Affairs Officer

Phoenix Labs.; Clonee; On-site; EUR 45,000 - 70,000; Full time

Job summary

An established industry player is seeking a Senior Regulatory Affairs Officer to join their dynamic team in a rapidly growing pharmaceutical group. This role offers the chance to ensure compliance with regulations, manage license transfers, and mentor junior team members. The ideal candidate will possess a strong background in regulatory affairs, with a keen eye for detail and the ability to thrive under pressure. This is an exciting opportunity to contribute to a company that is making significant strides in the pharmaceutical sector, providing innovative solutions in both OTC and prescription medicines.

Qualifications

• 3-4 years of experience in Regulatory Affairs is essential.
• Ability to work under pressure and meet deadlines.

Responsibilities

• Ensure compliance with regulations and standards for products.
• Prepare Module 1 documentation for National Applications.

Skills

Regulatory Compliance

Attention to Detail

Knowledge of MRP, DCP, CP

Medical Devices Knowledge

Time Management

Education

Degree in Life Sciences or related field

Job description

Role: Senior Regulatory Affairs Officer

Location: Office: Suite 12, Bunkilla Plaza, Bracetown Business Park, Co. Meath, Ireland

This is a great opportunity to join a pharmaceutical group which is enjoying significant growth both in Ireland/UK and internationally. Our group of companies are proud of our expanding business which includes market leading brands across OTC and Prescription medicines.

Due to this continued growth, we are now recruiting for this new position which will report into the Regulatory Affairs Manager.

Key responsibilities:

• Ensuring the Company’s products comply with all relevant regulations and standards
• Knowledge and execution of Type IA, IB and II Variations
• Licence transfers in various international territories
• Review of promotional material for medicinal products
• Preparation of Module 1 documentation for National Applications
• Prepare for and participate in meetings with Regulatory Authorities
• Deal with regulatory aspects of internationalising products and applying for reclassification of products
• Train and mentor more junior team members on Regulatory processes and compliance requirements
• Monitor and interpret regulatory trends and changes relevant to the industry and keep the Company appraised of these

Knowledge & Experience:

• Highly resilient and adaptable, able to work under pressure and within time constraints
• Drives results on a timely basis and sees things through to conclusion
• Knowledge of MRP, DCP, CP
• Knowledge of medical devices highly desirable
• Excellent attention to detail and organisational skills
• Capable of working on own initiative and taking responsibility for course of action
• 3-4 years previous experience essential

Get in touch to learn more about these roles and discover what it’s like to be part of our exciting journey.

Send your CV to: [e-mail]