高级项目总监（商业法规事务，远程办公）
Senior Program Director (Commercial Regulatory Affairs, Fully Remote)
我们的客户是生物技术和生命科学领域的全球领导者，现正在寻找一名“高级项目总监，商业法规事务”。
地点：加利福尼亚州南旧金山（完全远程）
时长：长期合同（可能进一步延长）
薪资：W2方式，每小时120-127美元
公司福利：医疗、牙科、视力保险、带薪病假、401K
职位简介
在此职位中，您将为美国商业药品提供战略法规指导。您将领导促销审查委员会（PRC），审核并批准广告和宣传材料，并与市场、医学事务、法律和合规团队紧密合作，确保符合FDA的沟通要求。该职位提供了在快速发展的生物科技环境中塑造创新疗法商业法规策略的机会。
主要职责：
- 领导促销审查委员会（PRC）会议
- 审核并批准宣传和营销材料
- 提供关于广告和宣传声明的法规指导
- 与市场、法律和合规团队合作
- 支持FDA沟通和表格2253提交
- 确保符合FDA法规和医疗行业指南
任职要求：
- 需要学士学位；拥有药学博士（PharmD）、博士（PhD）、法学博士（JD）、工商管理硕士（MBA）、硕士（MS）等更高学位优先
- 在生物技术/制药行业拥有7年以上法规事务、商业法规、合规或广告与推广相关经验
- 精通FDA广告与推广法规、宣传审查和医疗合规知识
- 有领导跨职能团队和促销审查委员会（PRCs）的经验
- 具备出色的沟通能力、利益相关者管理和项目领导能力
优先技能：
- 商业法规事务
- 广告与推广（Ad/Promo）
- 促销审查委员会（PRC）
- FDA表格2253
- 医学、法律、法规（MLR）审查
- 产品上市支持
如感兴趣，请将更新的简历发送至 /
最初发布于 Himalayas
查看英文原文
Our client, a world leader in biotechnology and life sciences, is seeking a "Senior Program Director, Commercial Regulatory Affairs".
Location: South San Francisco, CA (Fully Remote)
Duration:Long-Term Contract (Possibility Of Further Extension)
Pay Rate: $120-$127/hr on W2
Company Benefits: Medical, Dental, Vision, Paid Sick Leave, 401K
Job Summary
In this role, you will provide strategic regulatory guidance for U.S. commercial pharmaceutical products. You will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. This position offers the opportunity to shape commercial regulatory strategy for innovative therapies in a fast‑paced biotech environment.
Key Responsibilities:
- Lead Promotional Review Committee (PRC) meetings
- Review and approve promotional and marketing materials
- Provide regulatory guidance on advertising and promotional claims
- Partner with Marketing, Medical, Legal, and Compliance teams
- Support FDA communications and Form 2253 submissions
- Ensure compliance with FDA regulations and healthcare industry guidelines
Qualifications:
- Bachelor's degree required; advanced degree (PharmD, PhD, JD, MBA, MS) preferred
- 7+ years of Regulatory Affairs, Commercial Regulatory, Compliance, or Advertising & Promotion experience in the biotech/pharmaceutical industry
- Strong knowledge of FDA advertising & promotion regulations, promotional review, and healthcare compliance
- Experience leading cross-functional teams and Promotional Review Committees (PRCs)
- Excellent communication, stakeholder management, and project leadership skills
Preferred Skills:
- Commercial Regulatory Affairs
- Advertising & Promotion (Ad/Promo)
- Promotional Review Committee (PRC)
- FDA Form 2253
- Medical, Legal, Regulatory (MLR) review
- Product launch support
If interested, please share your updated resume at /
Originally posted on Himalayas