Regulatory Affairs Manager CMC

Oxford Global Resources is seeking a Global CMC Regulatory Affairs Manager Consultant to support as external contractor on behalf of Oxford a top leading pharma company to support headquarters in Barcelona through our consulting services division.

Key Responsibilities

• Provide CMC regulatory insight and advice to multidisciplinary teams, as well as CMC technical functions on CMC/Quality regulations and guidelines according to the Agencies expectations for successful approvals.
• Provide significant contribution or leading efforts for the authoring of CMC documents for the submission to Health Authorities (HA), including MAA preparation, post‑approval variations and responses to HA questions, as well as IMPDs for products under development.
• Coordinate any CMC regulatory activity required to expand the company portfolio in different territories (e.g. LATAM, APAC, EMA), in close collaboration with internal stakeholders (International...