Director Global Regulatory Affairs (remote)

Merck KGaA Darmstadt Germany • Billerica, MA

394d • $173,900 - $260,900 • Remote

About The Position

The Director of Global Regulatory Affairs will represent Regulatory Affairs in Global Project Teams, leading the regulatory sub-team and ensuring alignment with global regulatory strategies. This role involves driving the regulatory submission process, managing high-quality documentation, and coordinating major regulatory agency interactions. The position requires strategic development of regulatory plans aligned with project goals and effective management of project resources within a matrix leadership framework.

Requirements

• Advanced degree with at least 5 years of relevant experience.
• Minimum of 3 years of recent oncology experience.

Nice To Haves

• Proven strategist with successful interactions with FDA or EMA.
• Strong matrix leadership skills.
• Excellent spoken and written English.

Responsibilities

• Represent Regulatory Affairs in Global Project Teams for assigned projects.
• Lead the regulatory sub-team (GRST) and ensure alignment with global regulatory strategy.
• Drive the regulatory submission process, managing and coordinating high-quality documentation and deliverables.
• Ensure optimal management of major regulatory agency interactions, including preparation of briefing materials and coordination of rehearsals.
• Develop regulatory strategies aligned with project development plans.
• Ensure effective management of project resource requirements within the GRST through matrix leadership.
• Participate in cross-functional and Global Regulatory Affairs initiatives.

Benefits

• Medical, vision, and dental insurance
• Life insurance
• Disability insurance
• 401(k) matching program
• Paid time off
• Paid holidays
• Short-term or long-term incentive compensation, including cash bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree