Manager, Study Start Up and Regulatory Affairs

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

📋 Description

• Formulate study start-up and regulatory strategies in accordance with regulatory requirements.

• Coordinate and manage study start-up deliverables from site selection to site initiation readiness.

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

• Oversee the entire study start-up and regulatory milestones.

• Gather, assess for completeness and compliance, and monitor essential study start-up documents.

• Investigate any incomplete, inaccurate, or missing documentation.

• Prepare reports and status updates for the study team regarding essential document collection, review, and approval.

• Ensure the negotiation and execution of clinical site agreements, ancillary agreements, and amendments.

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

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

• Track project tasks, allocated time, budgets, and actual hours spent versus budgeted hours; escalate issues that are out of scope.

• Support business development by engaging in BDMs and contributing to proposals, regulatory sections, costing, and budgets.

• Provide strategic input into bids and facilitate new business opportunities.

• Offer coaching, guidance, and performance feedback to team members.

• Assist senior management in acquiring new business.

• May oversee the management of staff.

• Perform other assigned work-related tasks.

⛳️ Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing, or an equivalent 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 leading/project management capacity.

• Demonstrated ability to successfully manage global projects.

• Familiarity with regulatory requirements and regulatory affairs.

• Experience in study start-up activities and regulatory processes.

• Capability to develop study start-up and regulatory strategies.

• Proficiency in managing projects of medium to high complexity.

• Knowledge of clinical site agreements, ancillary agreements, amendments, and country regulations.

• Skill in identifying, assessing, and mitigating risks that may influence study start-up and regulatory timelines.

• Ability to manage project budgets and track hours against those budgets.

• Capacity to contribute to business development meetings, proposals, regulatory costing, and budgets.

🏝️ Benefits

• Collaborative, international team environment.

• Opportunities for career advancement.

• Flexible work culture.

• Emphasis on work-life balance.

• Opportunities for coaching, guidance, and mentoring.

• Chance to contribute to meaningful work that brings safe and effective pharmaceutical treatments to patients.

• Collaboration with experts in clinical research, pharmacovigilance, and quality consulting.