Senior Manager, Regulatory and PV Delivery

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Provide franchise liaison between Ergomed Group and clients across multiple-project programs • Lead and manage high-complexity projects and regulatory deliverables • Coordinate and execute regulatory tasks while driving teams to meet targets and follow agreed procedures, trackers and templates • Provide strategic input to internal and external customers • Identify and mitigate risks through preventive measures • Resolve performance issues and delivery failures • Advise clients on complex queries and changes in local regulations and guidance • Participate in business development meetings and support new or repeat business • Develop and review regulatory sections of proposals, regulatory costing and budgets • Build professional relationships with local and international internal and external contacts • Train, coach and mentor junior staff; potentially line manage staff • Support client qualification activities • Ensure audit readiness and coordinate departmental audit/inspection participation and responses • Drive departmental and company initiatives and manage change implementation

🎯 Requirements

• Minimum 5 years within the pharmaceutical or CRO industry or a regulatory body • At least 3 years in a leading or project management role • Proven ability to successfully manage global projects • Expert knowledge of ICH GCP and/or GVP • Expert knowledge of relevant legislation and local requirements for territories of competency • Hands-on experience with post-marketing regulatory activities and lifecycle management highly recommended

🏖️ Benefits

• Remote work option • Flexible working environment • Growth opportunities • Collaborative team environment • Training, coaching and mentoring opportunities • Global reach and opportunities to work with international teams