Regulatory Manager

The role

The Regulatory Manager provides regulatory development advice and guidance for clinical trials. This person coordinates and prepares regulatory documents for submission to Regulatory Authorities and Ethics Committees.

What you will do

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities
• Develops and/or reviews documents for submission to Regulatory Authorities and/or Ethics Committees
• Serve as representative of Global Regulatory Affairs at project team meetings
• Works within a project team or leads projects for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists
• Maintenance of project plans, project trackers and regulatory intelligence tools
• Assist in development of Regulatory Affairs Specialists and other operational area staff
• Provide input into regulatory strategy and timeline development
• Participates in maintaining and executing corporate quality initiatives

Required qualifications

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
• Computer literacy (MS Office/ Office 365)
• Fluent in English
• 5 + years or more relevant regulatory affairs experience
• Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
• Specialized knowledge of regulatory activities for at least one major region (EU, US)
• Ability to understand clinical and pre-clinical study results
• Knowledgeable of clinical trials methodology
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
• Availability for domestic and international travel including overnight stays

Nice to have

• Graduate, postgraduate
• Possesses basic understanding of financial management

Benefits

• discretionary annual bonus
• health insurance
• retirement savings benefits
• life insurance
• disability benefits
• parental leave
• paid time off for sick leave and vacation

Before you apply

• Candidates must be legally authorized to work in the country of employment without employer sponsorship

About the company

Precision Medicine Group is an Equal Opportunity Employer.