Associate Director Regulatory Liaison - Oncology
$129k - $203.1kMerck
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
Vacancy posted 5 days ago
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