Regulatory Affairs Manager Healthcare (m/w/d)

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 headquartered in Barcelona through our consulting services division.

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. Collaborate in the assessment of Business Development opportunities in relation to CMC topics. Ensure compliance with global regulatory requirements and contribute to the development of internal global standard operating procedures and guidance documents as needed. Establish good collaboration and interactions across various functions and teams, such as manufacturing sites (CMOs), Quality Assurance, supply chain, etc Bachelor’s degree in Life Sciences or a related field. Fluency in English for business communication. Minimum 5 years in Regulatory CMC field for pharmaceutical products, ideally at a global level. Knowledge of regulatory frameworks for medical devices and food supplements desirable.