Manager, Regulatory Affairs - EMEA- Remote

About the role

The company is a global CRO providing clinical research services. This role owns regulatory affairs across the EMEA region, including coordinating submissions, mentoring staff, and ensuring compliance with evolving regulations.

What you'll do

• Review budgets and contribute to contract negotiations and feasibility efforts
• Coordinate and manage regulatory ethics committee submissions across EMEA, APAC and LATAM
• Maintain submission tracking and provide regulatory guidance to the project team
• Assist in preparing technical documentation such as IMPDs and IBs
• Coach and potentially line manage junior staff
• Communicate submission status to sponsors, project managers, CRAs and Medical Science staff

What they're looking for

• Minimum 5-7 years in pharmaceutical or CRO regulatory or start-up roles
• Proven leadership, planning and organizational skills
• Strong written and verbal English communication
• Experience with cross-cultural communication and business development support
• Background in medical, biological or related science and relevant regulatory knowledge
• Ability to work in a fast-paced, deadline-driven environment and manage multiple tasks

For applicants in Nigeria

• The listing states remote work and lists many countries; Nigeria is included in the location list, so the role is accessible to applicants in Nigeria.
• The listing does not specify a timezone requirement; confirm expectations before interviewing.
• The listing does not specify contractor vs employee status; confirm during interview process.
• Pay currency or salary range is not provided; confirm during the interview process.
• No visa or local work-authorization notes are stated beyond general eligibility; confirm work eligibility during the process.