Job Summary
An outsourced development services provider is filling a position for a Remote Regulatory Affairs Director.
Core Responsibilities Include:
- Providing support to multidisciplinary teams on the content, authoring and submission of a Biologics Licensing
- Providing advice on project and Regulatory strategies
- Utilizing your technical knowledge of biologics development/manufacturing to act as a technical expert in CMC
Skills and Requirements Include:
- Minimum of 12-15 years related experience in Regulatory Affairs CMC, in Pharma or CRO
- Experience supporting business development activities and people management
- Demonstrable technical expertise in at least one CMC discipline
- Thorough working knowledge of local and global Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines
