Manager, Study Start Up and Regulatory Affairs

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

📋 Description

• Develop regulatory strategies and manage the coordination and supervision of study start-up deliverables from site selection to site initiation readiness.

• Lead regulatory and study start-up activities for projects of medium to high complexity.

• Oversee the end-to-end management of study start-up and regulatory milestones.

• Gather, evaluate, track, and resolve issues related to essential study documentation.

• Create reports and status updates for the study team.

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

• Define and execute project-level strategies for study start-up and regulatory compliance.

• Identify, evaluate, and mitigate risks that may impact timelines.

• Foster relationships with clients, regulatory agencies, and internal stakeholders.

• Coordinate departmental deliverables, oversee budgets and hours, and escalate any out-of-scope work.

• Engage in business development meetings and assist in proposals, regulatory costing, and budget preparation.

• Provide strategic insights for bids and support new business initiatives.

• Mentor, coach, and provide performance feedback to team members.

• May oversee the management of staff.

• Carry out other job-related tasks as assigned.

⛳️ Requirements

• Graduate degree in Chemistry, Life Sciences, Nursing, or a related field, or a comparable blend of education and experience.

• 6–8 years of experience in the pharmaceutical or CRO sectors, or within a regulatory agency.

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

• Demonstrated capability to effectively manage global projects.

• Experience in study start-up and regulatory affairs operations.

• Understanding of regulatory standards and country-specific regulations.

• Proficiency in managing clinical site agreements, ancillary agreements, amendments, and essential documentation.

• Skill in developing regulatory strategies, proposals, regulatory costing, and budgets.

• Ability to identify, assess, and manage risks associated with study start-up and regulatory processes.

• Competence in monitoring project budgets and addressing out-of-scope work.

🏝️ Benefits

• Collaborative and international team environment.

• Opportunities for career advancement.

• Flexible working culture.

• Emphasis on work-life balance.

• Coaching, guidance, and performance feedback provided.

• Chance to contribute to meaningful work that aids in delivering safe and effective pharmaceutical treatments to patients.

• Diverse and inclusive workplace where every voice is valued.