Manager, Study Start Up and Regulatory Affairs

This is a fully remote position, open to applicants in Czechia.

📋 Description

• Formulate regulatory strategies in accordance with regulatory requirements.

• Manage and supervise study start-up deliverables from site selection to site initiation readiness.

• Direct study start-up and regulatory tasks for assigned medium- to high-complexity projects.

• Achieve study start-up and regulatory milestones comprehensively.

• Gather, evaluate, and monitor essential study start-up documentation.

• Investigate and address any incomplete, incorrect, or missing documents.

• Create reports and status updates for the study team.

• Negotiate and finalize clinical site agreements, ancillary contracts, and amendments.

• Identify, evaluate, and mitigate risks that could impact study start-up and regulatory timelines.

• Establish and nurture relationships with clients, regulatory agencies, and internal stakeholders.

• Assign departmental tasks, oversee project budgets and hours, and escalate any out-of-scope work.

• Engage in business development meetings and contribute to proposals, regulatory costing, and budgeting.

• Offer strategic insights for bids and assist with new business initiatives.

• Mentor, guide, and provide performance evaluations for team members.

• May oversee staff and carry out other assigned responsibilities.

⛳️ Requirements

• Advanced degree in Chemistry or Life Sciences, Nursing, or a relevant combination of education and experience.

• 6–8 years of experience in the pharmaceutical or CRO industry or with a regulatory body.

• Minimum of 3 years in a leadership or project management position.

• Demonstrated success in managing global projects.

• Familiarity with study start-up and regulatory affairs.

• Understanding of regulatory requirements and regulations specific to different countries.

• Capability to manage projects of medium to high complexity.

• Proficiency in developing regulatory strategies and contributing to proposals, budgets, and bids.

• Ability to provide strategic regulatory guidance, training, coaching, and mentorship.

• Competence in monitoring project budgets, comparing hours worked to budgeted hours, and recognizing out-of-scope work.

• Skill in establishing relationships with clients, regulatory bodies, and internal stakeholders.

🏝️ Benefits

• Collaborative, international team environment.

• Opportunities for career advancement.

• Flexible working conditions.

• Emphasis on work-life balance.

• Access to coaching, guidance, and performance feedback.

• Chance to engage in impactful clinical research that benefits patients.

• Commitment to a diverse and inclusive workplace.

• Supportive culture characterized by shared ownership and trust.