Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in Spain.

📋 Description

• Evaluate study budgets and costs in relation to contract negotiations, engage in business development initiatives, prepare regulatory segments of proposals and feasibility reports, and participate in bid defense meetings to fulfill business objectives.

• Oversee and manage submissions to regulatory and ethics committees while maintaining approvals across the EMEA, Asia Pacific, and Latin America regions, ensuring precise compilation, management, and tracking of submissions.

• Offer expert regulatory guidance and contribute to regulatory project initiatives. Clearly communicate the status of submissions to the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs personnel.

• Assist in the development of technical documentation such as IMPDs and IBs, review and provide recommendations on all pertinent documentation to ensure adherence to ICH GCP and country-specific regulations.

• Deliver training, coaching, and mentorship to junior staff members and may be required to supervise junior team members.

⛳️ Requirements

• A minimum of a four-year degree in medical, biological, physical, health, pharmacy, or a related science field, OR…

• A two-year degree or equivalent education/training (nursing degree or comparable life science degree) along with eight years of experience in clinical research (e.g., CRA, Regulatory Affairs).

• At least 5-7 years of experience within the pharmaceutical/CRO industry, demonstrating senior-level regulatory or clinical start-up expertise.

• Strong proficiency in cross-cultural communication and excellent skills in both spoken and written English.

🏝️ Benefits

• Competitive salary

• Flexible working hours

• Professional development budget

• Home office setup allowance

• Global team events