Regulatory Affairs Manager Salary in Ireland

Regulatory Affairs Manager job description

Job Title: Regulatory Affairs Manager

Overview/Summary of the Role:

The Regulatory Affairs Manager is responsible for ensuring compliance with regulations related to the development, manufacturing, and distribution of medical products. They work closely with cross-functional teams to prepare regulatory submissions, communicate with regulatory agencies, and develop regulatory strategies. The Regulatory Affairs Manager plays a critical role in ensuring that medical products are safe, effective, and meet regulatory requirements.

Responsibilities and Duties:

-Develop, implement and manage regulatory strategies and procedures for compliance with domestic and international regulations.

-Ensure regulatory submissions are prepared accurately and submitted in a timely manner to regulatory agencies.

-Communicate with regulatory agencies to answer questions and provide additional information as needed.

-Perform assessments of proposed changes to products to determine regulatory impact and communicate to appropriate stakeholders.

Regulatory Affairs Manager interview questions

Interviewer: Good morning, it's a pleasure to meet with you today. Could you please introduce yourself and tell us about your qualifications for this position?

Candidate: Good morning, thank you for having me. My name is [Name], and I have [Number] years of experience in regulatory affairs. I have a bachelor's degree in [Degree] and have worked for several reputable pharmaceutical companies.

Interviewer: That's great to hear. Can you tell us about your experience with regulatory filings and submissions?

Candidate: Of course. I have experience with both domestic and international filings for various drug products, including INDs, NDAs, and ANDAs. I have managed the entire submission process from start to finish, and am familiar with FDA regulations and guidelines.

Interviewer: That's impressive. Can you walk us through how you stay up to date with changes in regulatory requirements?

Candidate: I make sure to constantly review FDA updates, attend conferences and meetings, and network with colleagues in the industry to stay informed. I also conduct regular training sessions for my team and make sure we are all up to date on any changes.

Regulatory Affairs Manager Salaries by cities in Ireland

The highest salary for Regulatory Affairs Manager in Ireland can be found in Dublin.