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Manager, Regulatory CMC

A leader in therapeutic antibodies, ImClone Systems is committed to advancing oncology care by developing a portfolio of novel targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. Founded 25 years ago, ImClone Systems has a rich culture of biotechnology innovation and leading-edge medical science. Our deep expertise in molecular biology, oncology, genomics and antibody engineering has helped us establish a robust pipeline of products that are in various stages of clinical development and span virtually all major solid tumor types.

The Manager, Regulatory CMC is responsible for maintaining competent knowledge of current / emerging regulations, guidance documents and corporate/industry standards, with an ability to evaluate same for impact on tactical operations. Good technical knowledge, provides committed, value-added effort in support of development projects and approved products. Must be detail-oriented with good oral and written communications skills; able to prepare accurate, clear and concise regulatory documents and manage the quality review process. Excellent time management skills essential; must be able to multi-task and drive timelines for deliverables. The position is primarily tactical however strategic insight is required.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Will have an in-depth understanding of regulatory CMC requirements, including FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive).
2. Reviews websites and develops initial impact assessment of draft regulatory guidance, communicating changes in regulatory requirements to senior regulatory management.
3. Provides regulatory guidance to ensure development activities are compliant with relevant regulations and in line with current global guidance.
4. Communicates regulatory strategy and guides manufacturing in developing data for approval of post-marketing changes.
5. Works with development teams and Regulatory Operations to outline submission requirements and negotiate timelines for regulatory CMC submissions.
6. Prepares the CMC section of INDs, BLAs, CTAs, CTDs, amendments, supplements and annual reports, including the compilation and review of the required data, scientific reports, and written submission contributions.
7. Reviews and assesses the regulatory impact of all change controls/requests for the manufacture, testing and release of development and marketed products.
8. Assists in the implementation of processes and applications to support regulatory activities

ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:
1. Must have 3 – 5 years of pharmaceutical industry experience including a minimum of 2 years of regulatory or related experience.
2. Demonstrated knowledge of the drug development process and government regulations/guidelines, including US and international product registration.
3. Good oral and written communication skills with a focus on accuracy (vigilant attention to detail) and clarity are essential.
4. Ability to supervise and mentor junior staff members.
5. BA/BS degree or equivalent experience.