Manager, Study Start Up and Regulatory Affairs

🔥 6 minutes ago

🇧🇬 Bulgaria – 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 strategies based on regulatory requirements • Coordinate and oversee all study start-up deliverables from site selection through site initiation readiness • Assist senior management in securing new business through BDM participation and proposal/budget contributions • Provide strategic regulatory guidance, training, coaching, and mentoring to junior team members • Lead study start-up and regulatory activities for assigned medium- to high-complexity projects • Manage end-to-end 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 updates on essential document collection, review, and approval status • 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 study start-up and regulatory timelines • Build and maintain relationships with clients, regulatory authorities, and internal stakeholders • Monitor assigned departmental deliverables, project budgets, hours spent versus budgeted, and out-of-scope work • Develop and review regulatory sections of proposals, regulatory costing, and budgets • Provide strategic input into bids and contribute to winning new business • Coach, guide, and provide performance feedback to team members • Line manage staff members when required • 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 • Experience with study start-up and regulatory affairs • Knowledge of regulatory requirements and country regulations • Ability to manage medium- to high-complexity global projects • Ability to develop regulatory strategies, proposals, regulatory costing, and budgets • Ability to negotiate and execute clinical site agreements, ancillary agreements, and amendments • Ability to identify, assess, and mitigate study start-up and regulatory risks

🏖️ Benefits

• Collaborative, international team environment • Career growth opportunities • Flexible work environment • Work-life balance • Coaching, guidance, and mentoring opportunities • Opportunity to contribute to meaningful clinical research that brings safe and effective pharmaceutical treatments to patients

📊 Check your resume score for this job

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

Upload Resume