Manager, Regulatory Affairs

Lonza

Basel or Visp, Switzerland

The Regulatory Affairs Manager, as part of Lonza CMO/CDMO Regulatory Affairs Biologics department, will support Customer activities focusing on chemistry manufacturing and controls (CMC) for Biologics projects.

In this exciting and dynamic role, you will work collaboratively with company personnel to coordinate the regulatory activities for clinical development (e.g. IND/IMPDs), product license applications (e.g. BLA/MAA), and life cycle management activities. The Regulatory Affairs Manager (CMC) will provide regulatory support and advice for internal and external Customers in line with defined regulatory plans and in response to ad-hoc questions. The role will also provide support for the site concerning change control deviation assessment and other activities such as the evaluation of new projects.

Key responsibilities:

Author/review the Module 3.2 dossier sections to support Customer filings for Biologics early phase projects (e.g. IND/IMPD), commercial projects (e.g. BLA/MAA), and life cycle variations submission for DS, DP, and Appendices, for newly developed products and/or site tech-transfers.
Represent the Regulatory Affairs department in the project team and lead and co-ordinate submission-related activities ensuring deliverables according to project timelines and according to Lonza procedures and good practices.
Track and negotiate within the project teams source documents availability required for clinical (e.g. IND/IMPD), and commercial (e.g. BLA/MAA) submissions.
Prepare and review responses to Health Authority submission review questions (RtQs).  
Preparation and review of briefing documents for scientific advice meetings with Health Authorities.
Attend Customer meetings and provide regulatory advice for assigned projects.
Communicate and escalate risks and issues to management and project teams as applicable.
Perform Regulatory assessments for deviations, change controls, and VCNs to ensure compliance with internal procedures and regulations.
Maintenance of Lonza sites facility registration filings with regulatory agencies and plant-level documentation (e.g. Site Master File and Japan FMA).

Key requirements:

Master's degree in biology, Chemistry, Biochemistry, Pharmacy or equivalent. Higher education (PhD, PharmD) or Regulatory Affairs Certification (RAC) preferred.
Experience (at least 5 years) in preparing and authoring M.3.2 CMC dossier sections for DS, DP, and Appendices through the product life-cycle is essential for this role.
Previous experience in CMO/CDMO environment is a clear advantage.
Extensive experience in leading project teams to successful filings and approvals.
Expertise in ICH guidelines and EU and US regulatory requirements for Biologics.
Knowledge/experience of Biologics manufacturing processes (e.g. Mammalian, Microbial, ADCs, Vaccines).
Experience in QA, MSAT, Operations, Analytical Development, and Quality control functions is a plus.
Fluency in English, German is a plus.

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