Senior Director, Regulatory Affairs
7 days ago
ProPharma Group is seeking a highly experienced professional to fill the role of Vice President, Nonclinical Emerging Therapies. This position will be responsible for leading the conduct of regulatory activities associated with the nonclinical development of therapeutic drug, biologic, and device products.
Key Responsibilities- Regulatory Leadership: Provide strategic guidance and oversight to ensure compliance with regulatory requirements and industry standards.
- Client Interface: Serve as the primary point of contact for clients on nonclinical matters, including new/emerging therapeutic modalities from discovery through clinical development and approval.
- Documentation Review: Conduct critical reviews of relevant documentation supporting regulatory applications, ensuring accuracy and completeness.
- Submission Preparation: Prepare and submit cogent, organized, and scientifically valid submissions to regulatory agencies, including the FDA.
- Regulatory Strategy: Develop and implement effective strategies to assist in obtaining regulatory approval of products with optimum cost effectiveness and compliance.
- Team Collaboration: Support new product development efforts, including interfacing with client development teams and/or contract organizations.
- Business Development: Assist with business development to win new business opportunities.
- Leadership Experience: 10+ years in positions of leadership in Regulatory Sciences within consulting and/or regulated drug/biologic development organizations.
- Team Management: Experience leading teams of technical professionals.
- Education: Master's degree in Life Sciences; PhD preferred.
ProPharma Group values diversity, equity, and inclusion, creating a workplace where each person can be their authentic self. We celebrate our differences and strive to empower employees to unleash their innovative, collaborative, and entrepreneurial spirits.
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