Manager, Study Start Up and Regulatory Affairs

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

📋 Description

• Develop a regulatory strategy and oversee the delivery of study start-up tasks from site selection to site initiation readiness.

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

• Manage the complete study start-up and regulatory timelines.

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

• Prepare reports and status updates for the study team.

• Negotiate and finalize agreements for clinical sites, ancillary services, and amendments.

• Define and implement regulatory strategies and study start-up plans at the project level.

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

• Cultivate relationships with clients, regulatory bodies, and internal stakeholders.

• Delegate departmental tasks, track budgets and hours, and escalate any out-of-scope work.

• Assist in business development through participation in BDM, proposals, regulatory costing, and budgeting.

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

• May oversee staff management and execute other assigned responsibilities.

⛳️ Requirements

• A graduate degree in Chemistry or Life Sciences, Nursing, or a comparable combination of education and experience.

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

• A minimum of 3 years in a leadership or project management capacity.

• Demonstrated capability to effectively manage global projects.

• Experience in developing regulatory strategies and coordinating study start-up tasks.

• Familiarity with regulatory requirements and regulations in various countries.

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

• Ability to identify, evaluate, and mitigate risks related to study start-up and regulatory processes.

• Capability to monitor project budgets and escalate any out-of-scope work.

• Ability to contribute to business development activities such as meetings, proposals, regulatory costing, and budgeting.

🏝️ Benefits

• A collaborative and international team environment.

• A flexible work culture.

• Emphasis on work-life balance.

• Opportunities for career advancement.

• Access to coaching, guidance, and mentoring.

• The chance to contribute to significant clinical research that delivers treatments to patients.

• A supportive workplace that values inclusivity and every individual's voice.