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What’s in it for you?

In this role, you will have an opportunity to be the Global Regulatory Lead for early-stage assets. You will form close partnerships with key stakeholders across the organization and on the core development teams. This role impacts Mersana by ensuring successful submission of INDs, CTAs, and BLAs. To be successful, you will have experience contributing to the successful submission of INDs/CTAs and NDAs/BLAs. You will have responsibility for ensuring the alignment of regulatory strategy with the program strategy and corporate objectives, and for contributing to the design, development, and implementation of department goals. This role reports to the Executive Director, Medical Writing and Regulatory Strategy.

How do you know if you’re the right fit?

You will have experience:

• Leading the development of global regulatory strategy for assigned programs via close collaboration with the Core Team and Senior Management of Regulatory Affairs.
• Advising teams and senior management on regulatory requirements and novel pathways for development programs.
• Developing, implementing, and maintaining standards, policies, and procedures for GCP regulatory compliance.
• Leading the Global Regulatory Teams for assigned projects.

The other stuff

This role is typically well suited for bachelor’s or master’s degree candidates in a scientific or life sciences discipline (Pharm.D. is highly desirable) with a minimum of 6 years of relevant and increasingly responsible experience in the Biotech/ Pharmaceutical Industry, specifically within Regulatory Affairs.

• Experience working in Oncology is preferred.
• Advanced understanding of major market (US/EU) clinical/nonclinical Regulatory requirements.

The position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation, and paid holidays.

Successful candidate must be authorized to work in the United States.

Mersana Therapeutics, Inc. is an equal opportunity employer.