Manager, Study Start Up and Regulatory Affairs

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

📋 Description

• Formulate study start-up and regulatory strategies in alignment with regulatory standards.

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

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

• Oversee the complete delivery of study start-up and regulatory milestones.

• Gather, evaluate, and monitor critical study start-up documents.

• Investigate any incomplete, inaccurate, or missing documentation.

• Create reports and status updates for the study team.

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

• Identify, evaluate, and address risks that impact timelines.

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

• Track project budgets and hours relative to budget; escalate any out-of-scope work.

• Assist in business development meetings, proposals, regulatory costing, and budgeting.

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

• Coach, mentor, and offer performance feedback to junior team members.

• Potentially oversee staff management responsibilities.

• Carry out other job-related tasks as assigned.

⛳️ Requirements

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

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

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

• Demonstrated ability to effectively manage global projects.

• Familiarity with study start-up and regulatory matters.

• Understanding of regulatory requirements and country-specific regulations.

• Capability to manage projects of medium to high complexity.

• Proficient in developing regulatory strategies and contributing to proposals, costing, and budgets.

• Skilled in managing timelines, quality standards, project budgets, and regulatory milestones.

🏝️ Benefits

• Collaborative, international team.

• Opportunities for career advancement.

• Flexible working environment.

• Work-life balance.

• Coaching, guidance, and performance feedback to facilitate professional growth.

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

• Supportive and inclusive workplace where every voice is valued.