Associate Director Regulatory Liaison - Oncology Job at Merck, Boston, MA

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  • Merck
  • Boston, MA

Job Description

Associate Director in Regulatory Affairs supporting oncology products at a pharmaceutical company. The role involves developing and implementing global regulatory strategies, managing agency submissions, and collaborating across functional teams to advance product registrations and compliance.

Responsibilities

  • Assist in regulatory agency communications and submissions including INDs, marketing applications, and periodic reports
  • Develop and implement regulatory strategy; prepare agency background packages and submission documents
  • Conduct research on regulatory guidelines, precedent, and competitive intelligence to inform strategy
  • Collaborate across functional teams including clinical, chemistry, manufacturing, and operations
  • Support product maintenance activities including quality compliance and label development

Requirements

  • Bachelor's degree with 5+ years pharmaceutical industry experience, or Master's with 2+ years, or doctoral degree in biological science/chemistry
  • Drug development experience
  • Prior regulatory agency interaction experience
  • Excellent written and oral communication skills
  • Strong scientific and analytical capabilities with attention to detail
  • Ability to manage multiple concurrent projects and priorities
  • Oncology product experience preferred

Compensation: $129,000 - $203,100

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