Manager, Study Start Up and Regulatory Affairs

🔥 6 minutes ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 21 days.
• No salary listed.

Apply Now

Find Similar Remote Jobs

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 strategy and coordinate and oversee study start-up deliverables from site selection through site initiation readiness • Assist senior management in securing new business by participating in BDMs and contributing to proposals and budgets • Provide strategic regulatory guidance, training, coaching, and mentoring to junior members • 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 for completeness and compliance, 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 • Define and implement project-level study start-up and regulatory strategies • Identify, assess, and mitigate risks affecting timelines • Maintain relationships with clients, regulatory authorities, and internal stakeholders • Monitor assigned team tasks, project budgets, hours spent versus budgeted, and escalate out-of-scope work • Develop and review regulatory proposal sections, regulatory costing, and budgets • Provide strategic input into bids and contribute to winning new business • Provide coaching, guidance, and performance feedback to team members • 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

🏖️ Benefits

• Work-life balance • Collaborative, international team • Career growth opportunities • Trusted to take ownership early • Passionate and collaborative team of experts • Diverse and inclusive workplace where every voice counts

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume