Senior Country Approval Specialist (Trial Activation)

About the role

The Senior Country Approval Specialist prepares, reviews and coordinates country submissions in line with the global submission strategy. The role is based in an office and involves working with regulators, investigators and internal teams on regulatory submissions and site activation.

Key responsibilities

• Prepare, review and coordinate local regulatory submissions (MoH, EC, special national applications such as gene therapy approvals, viral safety dossiers, import licenses) in line with the global strategy.
• Provide regulatory strategy advice to internal clients and develop and implement the local submission strategy.
• Act as the main contact for investigators and local regulatory authorities, and take part in submission, review and project team meetings.
• Coordinate with internal departments so that site start-up activities and submission timelines follow the critical path for site activation, and achieve the company's target cycle times.
• Prepare regulatory compliance review packages, liaise with the local SIA team and develop country-specific patient information sheets and informed consent forms.
• Maintain accurate trial status information in the database, oversee country study files against client SOPs, and mentor other SIA team members.
• Identify out-of-scope activities in contracts, support feasibility activities, and proactively resolve or escalate regulatory issues.

Required profile

• Bachelor's degree or equivalent, with relevant formal academic or vocational qualification.
• Previous experience comparable to 5+ years; equivalency through education, training and experience may be accepted.
• Good English and basic medical/therapeutic area knowledge.

Required skills

• Excellent knowledge of regional and national regulatory guidelines and EC regulations.
• Strong communication, negotiation and computer skills, with the ability to learn software quickly.
• Ability to work independently or in a team with minimal supervision and to mentor others.

Working conditions include an office or laboratory setting, possible exposure to biological fluids and electrical equipment, and personal protective equipment is required.