Regulatory Affairs CMC Manager (m/f/d)

Lonza

Ver: 54

Día de actualización: 21-11-2022

Ubicación: Porriño Galicia

Categoría: Legales / Contratos

Industria: Pharmaceutical Manufacturing

Posición: Mid-Senior level

Tipo de empleo: Full-time

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Contenido de trabajo

Spain, Porrino

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

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 s upport 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
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R45866

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