Job Description

Job Description:

Title: Associate Director, Regulatory Affairs (Contract)
Location: Remote or Hybrid
Contract Duration: 6-12 months (with potential extension)

About the Role: We are seeking an experienced Associate Director of Regulatory Affairs to join our team on a contract basis. This role will support regulatory strategy and execution across development programs, ensuring compliance with global health authority requirements. The ideal candidate is a proactive problem-solver with strong leadership skills and handson experience in regulatory submissions.

Key Responsibilities:

• Develop and implement regulatory strategies for assigned programs in alignment with business objectives.
• Lead preparation, review, and submission of regulatory documents (INDs, NDAs, MAAs, amendments, briefing packages).
• Serve as primary liaison with global health authorities and manage regulatory interactions.
• Provide guidance to crossfunctional teams on regulatory requirements and timelines.
• Monitor changes in regulations and assess impact on development programs.

Qualifications:

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• 8+ years of regulatory affairs experience in the pharmaceutical or biotech industry.
• Proven track record in leading regulatory submissions and interactions with FDA and/or EMA.
• Strong understanding of drug development process and applicable regulations.
• Excellent communication, organizational, and leadership skills.

Why Join Us?

• Opportunity to work on innovative programs in a dynamic environment.
• Flexible remote or hybrid work options.
• Competitive contract terms and potential for extension.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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