Full-Time Regulatory Affairs Specialist/Manager

Ergomed is seeking a Regulatory Affairs professional with extensive global clinical study management experience.

Opportunities are open globally; however, excellent written and communication skills in English, and a solid understanding of the clinical trials environment/ICH GCP are required.

Responsibilities:

• Lead and represent projects/deliverables (medium/high complexity) ensuring effective coordination, management, and execution of SSU/regulatory tasks, driving team performance to meet targets and procedures, trackers, and templates.
• Develop and manage setup activities (SSU RA Management Plan, procedures, and core documents), maintaining compliance with department standards.
• Support team members in project strategy, issue identification, and resolution.
• Author or contribute to complex technical/scientific/legal documentation preparation/review.
• Prepare, collect, review regulatory information/documents to support FDA, EMA, and national authority submissions (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs), and Ethics Committees/IRBs for initial authorization and maintenance, adhering to regulations.
• Provide expert regulatory advice to clients, ensuring consistent and high-quality advice across regions.
• Ensure clear and tailored communications with Regulatory Authorities and Ethics Committees/IRBs, seeking external guidance when necessary.
• Keep track of project budgets, hours vs. budget, and promptly escalate any issues/out-of-scope concerns for assigned team members.
• Assist in securing new/repeat business by participating in BDM activities, developing/reviewing regulatory proposal sections, and managing regulatory costing/budgets.
• Provide training, coaching, and mentorship to junior staff.

Qualifications:

• Bachelor's Degree in Chemistry, Life Sciences, or Medicine
• Minimum 3 years of experience in the CRO industry
• Proven ability to manage global projects
• Expert knowledge of ICH GCP and/or GVP, and comprehensive understanding of relevant global regulations
• Excellent written and verbal communication skills for clear and concise information presentation

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