Regulatory Affairs Manager Salary in Cambridge, Cambridgeshire

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.