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.
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 Pharma Sales, affiliates, CMO management, etc) as well as partners and potential vendors.
* 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
* Ensure to be up to date with CMC regulatory intelligence relevant to the company portfolio and pipeline.
Requirements, Skills, and Qualifications:
* 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.
* Strong scientific and technical CMC knowledge, along with strategic regulatory mindset. Good knowledge of international CMC regulatory legislation.
* Proven track record of effective collaboration with CMOs, partners and Health Authorities in gaining regulatory approvals and managing life cycle of approved products in different geographical areas.
* Demonstrable submission history experience for EU and other international territories
* Knowledge of regulatory frameworks for medical devices and food supplements desirable.
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