• , US

Company:  Confidential

Job Title: Dir./Sr. Dir. of Regulatory Affairs

Job Number: 74044

Location: , US

Job Description

An exciting new opportunity is available to join a growing regulatory team as a Director/Senior Director of Regulatory Affairs, reporting directly to the Chief Regulatory Officer. This individual will hold a crucial role within the organization, developing and overseeing regulatory strategies and compliance to ensure the successful development, registration, and commercialization of products.


* Develop regulatory strategies for product development. * Offer expertise in clinical research and compliance. * Collaborate with teams for global filings. * Support development management in strategy planning. * Provide regulatory advice in project meetings. * Ensure compliance with local and international regulations. * Advise project teams on regulatory matters. * Fulfill additional duties as needed.

Required Skills

* Bachelor’s degree in Biological Sciences, Pharmacy, or related field required; Advanced degree/certificate in regulatory affairs preferred. * 8-10+ years regulatory experience in pharmaceutical or biotech industry required. * Oncology experience preferred. * Strong knowledge of US drug development and regulatory requirements. * Proficiency with regulatory tools and databases. * Excellent time management and project coordination skills. * Support health authority inspections and readiness. * Effective communication skills for collaboration and representation.

Application Deadline: 2024-03-18


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