Manager, Study Start Up and Regulatory Affairs

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

📋 Description

• Formulate regulatory strategies and oversee study start-up deliverables from the selection of sites to the readiness for site initiation.

• Support senior management in acquiring new business by engaging in Business Development Meetings (BDMs) and aiding in the preparation of proposals and budgets.

• Offer strategic regulatory advice, training, coaching, and mentorship to junior team members.

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

• Manage the comprehensive delivery of study start-up and regulatory milestones.

• Gather, review for accuracy and compliance, and monitor essential study start-up documentation.

• Investigate any incomplete, inaccurate, or missing documents.

• Generate study team reports and provide status updates.

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

• Define and execute project-specific study start-up and regulatory strategies.

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

• Maintain relationships with clients, regulatory authorities, and internal stakeholders.

• Oversee assigned team tasks, project budgets, hours worked against budgeted hours, and escalate any out-of-scope work.

• Develop and review sections of regulatory proposals, regulatory costing, and budgets.

• Provide strategic insights into bids and assist in securing new business.

• Coach, guide, and provide performance feedback to team members.

• Execute other work-related tasks as assigned.

⛳️ 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 within a regulatory agency.

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

• Demonstrated ability to effectively manage global projects.

🏝️ Benefits

• Work-life balance.

• Collaborative, international team environment.

• Opportunities for career advancement.

• Empowered to take ownership early in projects.

• Dedicated and collaborative team of experts.

• A diverse and inclusive workplace where every voice is valued.