Executive Director, Regulatory Affairs – Global
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Job Description
Executive Director leading global regulatory affairs for biopharmaceutical company, focusing on international regulatory strategy and compliance for oncology products.
Responsibilities:
- lead and participate in global regulatory activities
- develop innovative global regulatory strategies
- provide strategic regulatory guidance for global development
- coordinate with internal and external stakeholders
- mentor junior staff
- oversee regulatory activities and submissions
- ensure compliance with global regulatory requirements
Requirements:
- BS/ MS/ PhD in a relevant scientific discipline
- minimum of 15 years in the biopharmaceutical industry
- 10+ years of experience in pharmaceutical or biotech regulatory affairs
- experience in clinical regulatory affairs for oncology products
- ability to translate regulatory requirements into practical workable plans
- diverse experience with regulatory activities
- strong organizational skills
- effective interpersonal and communication skills
- demonstrated ability to achieve high performance goals in a fast-paced environment
Benefits:
- annual performance incentive bonus
- new hire equity package
- medical insurance
- dental insurance
- vision insurance
- 401(k) match
- PTO
- paid holidays
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