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Michael Page International Inc. Executive Director - Regulatory Affairs in Boston, Massachusetts

USD220,000-USD270,000

  • Proactively develop and execute creative and thorough global regulatory strategies for assets in clinical development through collaborative partnership and regulatory leadership within the project team

  • Ability to assess and develop solutions for complex regulatory challenges

  • Function as a strategic regulatory partner within the cross-functional project team to execute on program strategies and deliverables

  • Serve as the regulatory point of contact to the project team and regulatory authorities for assigned projects.

  • Lead development and strategy of regulatory documents submissions to CTAs, INDs, NDAs/BLAs, and MAAs

  • Lead interactions with regulatory authorities

  • Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.

  • Lead, manage, mentor, and develop direct reports including goal setting and performance management.

  • Ensures that adequate regulatory resources (internal and external) are planned and allocated to ensure on time and quality regulatory submissions.

  • Identifies and leads initiatives to improve processes and procedures in the regulatory affairs department.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

  • BS Degree. Advanced degree, or MS in regulatory affairs is preferred

  • 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or clinical drug development experience.

  • Experience in reviewing, authoring, or managing components of regulatory submissions.

  • Experience with leading major drug development interactions with regulatory authorities

  • Prior experience working in rapidly growing pharmaceutical organizations is desirable

  • Thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of the developing landscape of regulations and guidelines

  • Expert knowledge of US and Ex-US regulatory requirements for prescription drugs

Our client is an exciting and disruptive clinical stage biotech company with a wide pipeline focused on developing treatments for inflammatory conditions, cancers, and respiratory and lymphatic diseases, among others.

  • Highly competitive base salary + benefits package

  • Opportunity to drive Regulatory strategy at a rapidly growing organization focused on orphan drugs

  • Ample opportunity for career growth and professional development

  • Full-time remote

  • Opportunity to work on extremely diverse and robust product pipeline

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