Regulatory Manager / Senior Regulatory Manager

The role

You will provide regulatory strategy and development guidance for clinical trials and regulatory agency meetings. You will coordinate and prepare 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 and 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 for new study opportunities
• Participates in maintaining and executing corporate quality initiatives

Required qualifications

• Bachelors degree, or equivalent experience
• 5 years Regulatory experience required for the Manager level
• 7 years Regulatory experience required for the Senior Manager Regulatory level
• Informed knowledge of all aspects of the drug development process
• Specialised knowledge of regulatory activities for at least one major region (EU, US)
• Regulatory affairs experience working for a CRO or within the Pharmaceutical Industry
• Experience leading Clinical Submissions
• 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
• Communicates effectively in the English language both verbally and in written form

Nice to have

• ideally in a scientific or healthcare discipline

Benefits

• discretionary annual bonus
• private medical insurance
• MultiSport Card
• life insurance
• pension
• home working allowance
• vacation

Before you apply

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

About the company

Precision for Medicine is a CRO that integrates clinical trial execution with scientific knowledge, laboratory expertise and advanced data sciences. The company has a strong focus on Oncology and Rare Disease.