招聘Regulatory Affairs总监或更高级（新泽西或马里兰）

• 工作地新泽西优先

• 美国当地是新筹建团队，暂无下属，汇报给国内RA VP

• 级别为总监或高级总监
  

• 属于临床CRO公司

• 年薪+年终奖+股权激励
  

Primary Responsibilities:

• Manages regulatory projects and closely collaborates with Clinical Operations, Medical Affairs, other technical departments and external clients to coordinate and implement submission strategy and content in a global clinical pharmaceutical development environment.

• Provides updates on strategic regulatory intelligence, such as new regulations, guidance, ODACs, competitive product applications and approvals, etc.

• Provides regulatory intelligence to inform regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios.

• Provides tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original BLAs and international Marketing Authorization Applications and their respective amendments/supplements.

• Coordinates and manages regulatory submission documents (e.g., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission ready content. Coordinate interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend/steer review meetings, and incorporate revisions.

• Manages the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems.

• Works with clients to compile and review regulatory submissions for completeness and quality, ensuring that client’s practices are in conformance with the latest health authority and industry submission standards.

• Assists with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.

Position Requirements:

• Takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.

• Understands and interprets data/information and its practical application.

• Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.

• Strong understanding of pharmaceutical or biological drugs development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management, and medical terminology.

• Working knowledge of manufacturing research and development.

• Strong time and project management skills.

• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.

• Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.

Education and Professional Experience

• Bachelor’s degree (MS, PhD, Pharm D preferred), in Life Sciences/Health Related field, from an accredited college or university with 10 or more years’ drug development or related experience with 7+ years in Regulatory Affairs.

• Extesive knowledge of regulatory requirements.

• Proficient in pertinent software & tools.

• Must be knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).

往期文章：

我的目标

1）海外生物医药人才的寻访

2）海外生物医药项目融资和引进

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