Job: Regulatory Affairs Manager

A leading company in the pharmaceutical industry is currently seeking a Regulatory Affairs Manager to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details:

1) Prepare submissions to both US FDA and international regulatory agencies
2) Ensure quality of submissions generated and correspond with regulatory agencies and customers regarding submissions
3) Interpret and apply regulations to issues that require interpretation of FDA guidelines and regulations
4) Develop and maintain high level relationships with key contacts in regulatory agencies
5) Maintain records of all regulatory submissions, associated letters of authorization, and technical data packages provided to customers
6) Maintain records of all correspondence with regulatory agencies and customers
7) Fulfill customers request for regulatory documentation, onsite visits to customers as needed to provide regulatory support
8) Answer questions regarding DMF content
9) Develop procedures to improve efficiency and accuracy of regulatory filings
10) Compile and submit site master files to support company GMP operations
11) Develop direct reports to ensure optimal performance and ability to meet future business needs by setting objectives, career development activities, and skill development
12) Ensure adequate environmental, health and safety training is received
13) Ensure a positive safety culture is sustained

Critical Requirements

1) A university degree is required (preference will be given to those with degrees in a relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceutical industry is strongly preferred
4) Preference will be given to people with recent experience in regulatory affairs management

If you think you’re a perfect match for this role, you could be just the person to fill the position. Please apply ASAP.