Senior Manager, Regulatory Affairs

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

📋 Description

• Evaluate study budgets and costs in relation to contract negotiations, engage in business development initiatives, prepare regulatory components of proposals and feasibility reports, and attend bid defense meetings to fulfill business objectives.

• Oversee and manage submissions to regulatory and ethics committees, ensuring that approvals are maintained across the EMEA, Asia Pacific, and Latin America regions while accurately compiling, managing, and tracking submissions.

• Offer expert regulatory guidance and contribute to regulatory project efforts. Communicate submission statuses effectively with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs teams.

• Assist in the creation of technical documentation such as IMPDs and IBs, review and provide recommendations on all pertinent documentation to guarantee compliance with ICH GCP and specific country requirements.

• Deliver training, coaching, and mentoring to junior staff members, and may be required to supervise junior staff.

⛳️ Requirements

• A minimum of a four-year college degree with a major in medical, biological, physical, health, pharmacy, or a related science, OR… a two-year college degree or equivalent education/training (nursing degree or equivalent life science degree) along with eight years of experience in clinical research (e.g., CRA, Regulatory Affairs).

• At least 5-7 years of experience within the pharmaceutical/CRO industry, demonstrating senior-level expertise in regulatory or clinical start-up processes.

• Strong proficiency in cross-cultural communication, with advanced skills in both spoken and written English.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Professional development opportunities

• Flexible working hours

• Paid time off