Job Details

  • Title: Regulatory Affairs Manager (CMC)
  • Code: RCI-08843
  • Location:
  • Posted Date: 09/09/2020
  • Duration: 6 Months
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  Job Description

Remote till January, 2021 and then expected to report in Oceanside, CA.

The Manager, Regulatory Affairs, CMC will provide key Regulatory CMC support for primarily biologic investigational drugs being evaluated for the treatment of oncology, HIV and liver diseases. May also work on small molecule investigational drugs and life-cycle management of marketed products. The Manager, working with the project teams and regional regulatory leads in the US, EU and other countries, will support the development of global regulatory strategies, provide regulatory guidance, and critically review documents for submission to regulatory authorities. May serve as US Regional Lead on cross-functional/ cross-regional Regulatory Submission Teams. May participate on other Subteams, as applicable.

  • Responsible for preparing and submitting complex regulatory documents which require interaction with departments outside of Regulatory Affairs CMC for investigational, primarily biologic, products, in line with ICH requirements, regional requirements and scientific and company policies and procedures
  • Examples include original INDs and BLAs, amendments, supplements, annual reports and license renewals
  • May provide strategic Regulatory CMC advice as appropriate
  • Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling and for ensuring product packaging and associated information is included in regulatory submissions or updated and maintained in accordance with the product licenses, as applicable
  • Maintains knowledge of regulatory requirements and communicates changes in regulatory information to Regulatory project teams in a timely manner
  • Work cooperatively with regional regulatory sites to support the accurate and timely communication of critical information
  • Provide support for cGMP activities as they relate to regulatory affairs
  • Work is performed cross-functionally within a matrixed organization under limited direction of a senior Regulatory Affairs CMC professional and line manager
Knowledge, Experience and Skills:
  • Must work well under demanding deadlines and have excellent attention to detail
  • Excellent organizational skills and ability to work on several projects with tight timelines is required
  • Requires a bachelor’s degree (scientific field preferred) and 5-7 years of relevant experience in Regulatory Affairs CMC for biologics
  • Experience with BLA submissions desired
  • Excellent verbal and written communication skills and interpersonal skills are expected
  • Must be knowledgeable of regulatory requirements, including ICH requirements and US regional requirements