Manager, Study Start Up and Regulatory Affairs

🔥 0 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

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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

• Develop study start-up and regulatory strategies based on regulatory requirements • Coordinate and oversee all study start-up deliverables from site selection through site initiation readiness • Lead study start-up and regulatory activities for assigned medium- to high-complexity projects • Manage end-to-end delivery of study start-up and regulatory milestones • Collect, review, and track essential study start-up documents • Investigate incomplete, inaccurate, or missing documents • Prepare study team reports and status updates • Negotiate and execute clinical site agreements, ancillary agreements, and amendments • Identify, assess, and mitigate risks affecting timelines • Build relationships with clients, regulatory authorities, and internal stakeholders • Monitor project budgets and hours against budget; escalate out-of-scope work • Support business development meetings, proposals, regulatory costing, and budgets • Provide strategic input into bids and contribute to winning new business • Coach, guide, mentor, and provide performance feedback to junior team members • Potentially line-manage staff • Perform other work-related duties as assigned

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience • 6–8 years within the pharmaceutical or CRO industry or a regulatory body • At least 3 years in a leading/project management role • Proven ability to successfully manage global projects • Experience with study start-up and regulatory affairs • Knowledge of regulatory requirements and country regulations • Ability to manage projects of medium to high complexity • Ability to develop regulatory strategies and contribute to proposals, costing, and budgets • Ability to manage timelines, quality standards, project budgets, and regulatory milestones

🏖️ Benefits

• Collaborative, international team • Career growth opportunities • Flexible work environment • Work-life balance • Coaching, guidance, and performance feedback to support development • Opportunity to contribute to meaningful work helping bring safe and effective pharmaceutical treatments to patients • Supportive, inclusive workplace where every voice counts

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