Global Biotech CMC Regulatory Lead Global Pharmaceutical Company Europe

5 days ago

Budapest, Budapest, Hungary Carbyne Full time €80,000 - €120,000 per year
Carbyne has been retained by a European pharma company to search & select a CMC Biotech Regulatory Lead. In this newly created role you will support the CMC regulatory strategy of biosimilar portfolio from development to licensing. The company has an exciting portfolio of biological compounds in pre-clinical, early clinical stages as well as a marketed product.

The purpose of the role is to prepare and oversee CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support. 

The position can be filled from any country on the European continent.

Main responsibilities include:

You will be accountable for the delivery of the CMC dossiers with high quality standards and within portfolio defined timelinesDevelopment of CMC regulatory strategy for the products in the portfolio will be a key success componentOutline international regulatory CMC method to assist with regulatory proposals from clinical development to the post-approval phase Provide guidance for regulatory CMC aspects of product in multiple projects; identify regulatory considerationsDevelop, author and/or review documents to ensure that all submissions conform to health authority guidelinesDrive Regulatory CMC discussions and interactions to facilitate review and approval of submissions for all CMC aspects of the dossier.When needed, you will handle interface with project governance committees both internally and externallyGuarantee that all actions are carried out to company's international quality and safety standards​​​Provide interpretation of regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programsIdentify, solve and communicate regulatory CMC risk and key mitigationsSupport the creation and maintenance of CMC submission templatesEvaluate CMC change controls We appreciate your application if you have:​​​​​
At least a MSc in life science or relevant scientific field (e.g. Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering)5+ years of experience in the pharmaceutical industry, with demonstrated experience in the regulatory CMC activities of biological compounds (preferably mAb therapies but vaccines experience is considered)Previous experience in the CMC regulatory support of biological therapeutics ideally from development to commercializationPrevious experience with a Competent Authority as an assessor of biologicals is an advantageStrong knowledge of current relevant regulations; US, EU, APAC and ROW experience an assetStrong knowledge of cGMPGood influencing, negotiation skills and ability to establish common ground with stakeholders, balancing out conflicting interests and reaching consensusFull professional proficiency in English

 

Are you interested? Do not hesitate to submit your CV and we would be happy to contact you to share the further details or call Gergely Kosznovszki on phone number.

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