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Regulatory Compliance Director
2 months ago
The Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.
Key Responsibilities:
- Provide high-level strategic and operational regulatory direction and mentorship on projects, including general regulatory strategies, regulatory requirements for clinical studies and marketing approvals in international markets, regulatory strategic development plans, and risk assessments.
- Lead Health Authority interactions and oversee, contribute to, and/or prepare regulatory submissions.
- Perform and prepare due diligence assessments, including risk mitigation strategies.
- Prepare regulatory teams for and lead meetings, including face-to-face interactions, with Health Authorities.
- Continually build upon and maintain knowledge of the global regulatory landscape, regulations, and guidance.
- Manage the development of the ongoing global regulatory strategy.
Requirements:
- Postgraduate degree (MS/PhD/PharmD) in Pharmacy, Biological Sciences, or other related discipline.
- 15+ years of global regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry.