Full-Time Regulatory Affairs Senior Specialist/Manager

Ergomed is seeking Regulatory Affairs professionals with experience in managing global complex clinical studies.

Main Responsibilities:

• Assume leadership for projects, ensuring coordination and execution of regulatory tasks.
• Develop strategy and manage set up activities ensuring compliance with department standards.
• Support team members in preparing project strategy and providing resolution.
• Author/contribute to the preparation and review of complex technical/scientific/legal documentation.
• Ensure preparation, collection, and review of regulatory information to support submissions to FDA, EMA, and national authorities.
• Provide expert advice to Clients addressing complex regulatory queries.
• Ensure communications with Regulatory Authorities and Ethics Committees are carefully tailored.
• Monitor project budgets and escalate any out-of-scope issues.
• Assist in securing new business by participating in BDMs and developing regulatory sections of proposals.
• Provide training, coaching, and mentoring to junior staff.

Requirements:

• Bachelor's Degree in Chemistry, Life Sciences, or Medicine.
• Minimum 3 years within CRO industry.
• Proven ability to manage global projects.
• Expert knowledge of ICH GCP and/or GVP.
• Very good written and verbal communication skills.

We prioritize diversity, equity, and inclusion, offering training, career development, and a supportive environment with global collaboration opportunities.

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