Regulatory Affairs CMC Associate

Responsibilities

• Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology, HIV and liver disease.
• The Associate, working with the project team and regional regulatory leads in the US, EU and other countries, will support documentation for submission to regulatory authorities.
• May serve as regional lead on cross-functional/ cross-regional Regulatory Submission Teams.
• Responsible for preparing and submitting regulatory documents which require interaction with departments in and outside of Regulatory Affairs CMC for investigational and commercial biologics and small molecule products, in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Examples include original INDs, NDAs, BLAs, amendments, supplements, annual reports and license renewals.
• Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs and work instructions.
• Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory Department.
• Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling and for ensuring product packaging and associated information is updated and maintained in accordance with the product license as applicable.
• Maintains knowledge of regulatory requirements and communicates changes in regulatory information to line manager and 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 CMC.
• Work is performed cross-functionally within a matrixed organization under supervision of senior Regulatory Affairs CMC professionals and line manager.

• BS/BA Degree in Scientific field preferred and 4 years of relevant Pharmaceutical/Biotech industry experience, for example in Regulatory Affairs CMC.
• Excellent organizational skills and ability to work on multiple projects with tight timelines is required.
• Excellent verbal and written communication skills and interpersonal skills are expected.
• Must work well under demanding deadlines and have excellent attention to detail.
• Must have a reasonable understanding of regulatory requirements, including ICH requirements and US regional requirements.