Manager, Study Start Up and Regulatory Affairs

🔥 21 minutes ago

🇵🇹 Portugal – 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 regulatory strategies based on regulatory requirements • Coordinate and oversee study start-up deliverables from site selection through site initiation readiness • Assist senior management with new business development through BDM participation and proposal/budget contributions • Lead study start-up and regulatory activities for medium- to high-complexity projects • Manage end-to-end 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 budgeted amounts; escalate out-of-scope work • Develop and review regulatory proposal sections, costings, and budgets • Provide strategic input into bids and contribute to winning new business • Coach, guide, and provide performance feedback to team members • Potentially line manage staff • Perform other assigned work-related duties

🎯 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 • Knowledge of regulatory requirements and study start-up processes • Ability to manage medium- to high-complexity global projects • Ability to develop regulatory strategies, proposals, regulatory costing, and budgets • Ability to manage project timelines, budgets, deliverables, risks, and issues • Ability to provide strategic regulatory guidance, training, coaching, and mentoring

🏖️ Benefits

• Collaborative, international team environment • Flexible work culture • Work-life balance • Career growth opportunities • Supportive workplace culture • Coaching, guidance, and performance feedback • Opportunity to work on meaningful clinical research that helps bring safe and effective treatments to patients

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