Regulatory & Medical Affairs Project Manager

Regulatory & Medical Affairs Project Manager

Location: Burlington, MA

Onsite Flexibility: Remote

Contract Details

• Position Type: Contract
• Contract Duration: 4 months
• Pay Rate: $120.00 / Hour (USD)
• Shift / Schedule: EST time zone highly preferred
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

The Global Regulatory Lead is responsible for the global regulatory strategy and execution.

Key Responsibilities

• Represent Regulatory Affairs in Global Project Team(s) for your assigned project(s).
• Lead the regulatory sub-team (GRST) for your assigned project(s). Ensure alignment of all GRST functions.
• Drive the regulatory submission process for all types of submissions through to approval. This includes the management and coordination of the preparation of all regulatory documentation, and ensuring all submission deliverables are of high quality. Partner with Regulatory Project Management and Submission Management.
• Ensure optimal management of major regulatory agency interactions for your assigned projects including preparation of briefing materials, co-ordination of rehearsals and minutes. This may be done by an experienced Regional Regulatory Lead with strong support from the GRL.
• Develop optimal regulatory strategies that are aligned with the development plan for assigned projects.
• Matrix leadership role of GRST ensure project resource requirements are suitably managed.
• Participate in cross-functional and GRA initiatives.

Required Skills

• Experienced strategist with a record of successful HA interactions with FDA or EMA.
• Demonstrated strong matrix leader.
• Excellent spoken and written English.

Education Requirements

• Advanced degree required.

Required Experience

• At least 6 years of relevant experience.
• A minimum of 3 years of recent oncology experience.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Important Notes

• Interviews will be virtual.
• Immediate start required candidate needed to start as soon as possible; ideally before the 17th or 18th due to a resignation. However, the client will wait for the right candidate.
• Must be based in the U.S. EST time zone is highly preferred.

About the Client

This research-intensive biopharmaceutical company is one of the world's largest life sciences organizations, with annual revenues exceeding $65 billion and approximately 75,000 employees operating across every continent. Its portfolio spans oncology, vaccines, infectious diseases, cardiometabolic health, immunology, neuroscience, and ophthalmology including the world's best-selling oncology therapy and a leading HPV vaccine that has contributed to meaningful reductions in cervical cancer rates worldwide. Recognized by Forbes as one of the World's Best Employers and ranked 15th globally among top biotech and pharmaceutical employers by Science Magazine, this organization employs scientists, regulatory affairs professionals, clinical operations specialists, data and technology experts, and business operations professionals who collaborate on science that directly impacts patients and families around the world.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-10795 Industry: Healthcare

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