Regulatory Affairs CMC Manager

Regulatory Affairs CMC Manager

Lonza

O Porriño, Spain

Lonza Biologics Porriño site is a commercial/late phase clinical mammalian manufacturing site. The Site Regulatory Affairs CMC Manager will be responsible to handle and facilitate on-site regulatory CMC related product specific activities. This will entail to ensure site products/programs adherence to regulatory requirements (for clinical, commercial approval and product life cycle maintenance). In alignment with Lonza Site Quality and Customer Regulatory, the position will ensure effective regulatory support to process transfers, change requests and deviations, ensuring site product specific regulatory compliance and submission readiness. This includes dossier preparation (writing and or review of clinical, commercial and product life cycle maintenance customer submissions).

Key responsibilities:

  • Provide CMC regulatory advice for the products manufactured at or planned to be manufactured on site (project transfers);
  • Interface with the site (quality and operations) and customers for identification of issues and factors that may trigger a regulatory activity (change request management and deviations assessment). Supports the site in generation of effective change control strategies, considering regulatory relevant information, current regulatory requirements and potential regulatory hurdles;
  • Interface with the site (quality and operations) and external customers in the preparation (writing or review) of customer regulatory filings (CMC modules relevant to Lonza activities);
  • Coordinates the review by Site SMEs for submission readiness, ensuring technical congruency and consistency with source documents. Supports the preparation of CMC responses to health authority questions;
  • Monitor and enter relevant data into the internal tracking systems for department deliverables/KPIs and ensures information is accurate and current;
  • Maintenance of the Site Master File relating to the site’s facilities and operations and support site specific compliance activities and if requested provide regulatory status and relevant registration documentation. Provides regulatory support during local HA inspections.

Key requirements:

  • 7 to 10 years of Regulatory CMC experience in biotechnology (Pharmaceutical/Biotech industry) with recombinant proteins, monoclonal and conjugated antibodies;
  • Or a minimum of 5 to 6 years of Regulatory CMC experience plus previous experience Quality Assurance and or Process Development;
  • Extensive experience (more than 15 years) in the area of CMC compliance of biotechnoly/biologicals would also be considered;
  • Proven experience in handling manufacturing site CMC regulatory activities and interfacing with operational groups;
  • Experience with recombinant proteins, monoclonal and conjugated antibodies.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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