Senior Technical Regulatory Affairs Manager

Senior Technical Regulatory Affairs Manager

Idorsia Pharmaceuticals

Basel, Switzerland

Job Responsibilities

• Write, update, and keep track of the Module 2 (Quality Overall Summary) and the Module 3 (quality) of CTDs for global marketing applications,
• Write, update, and keep track of the Quality part of the IMPD, IND (and other technical regulatory documents) for global clinical trials application,
• Prepare Briefing Books and supportive documentation for Health Authority meetings (pre-IND, pre- NDA, End of Phase II, Scientific Advice meetings),
• Write the answers to the quality questions raised by the Health Authorities following the submission of global Marketing /Clinical Trial Applications and technical variations,
• Negotiate, plan, and coordinate with internal and external stakeholders (CMC and DRA project leaders, partners) strategies leading to regulatory submissions and clinical/commercial supplies,
• Assess and communicate the regulatory impact and regulatory requirements of products changes,
• Store regulatory documents and track versions within the relevant document management systems,
• Keep track of global submissions, approvals and/or implementation acceptability dates,
• Operational and strategical contribution to forms, guidelines, and procedures,
• Organize reviews (CMC team, Management, DRA, management committee), assess the comments and consolidate technical documents for global regulatory submissions,
• Ensure consistency between raw data and registration documents contents,
• Prepare and track Pre and Post approval synopsis,
• Store technical regulatory documents within the relevant document management systems using up- to-date dictionaries and meta-data.

Candidate's Requirements

• University degree (Msc, PhD) in Pharmacy (Pharm D), Chemistry or biology, or alternative technical/science university degree,
• Experience of at least 5 years in technical/CMC regulatory field or similar positions in the pharmaceutical industry,
• Good organizational and communication skills,
• Ability to proactively initiate and lead preparation of CMC documentation for filing activities,
• Ability to manage multiple tasks with competing priorities,
• Ability to manage complex projects,
• Ability to communicate clearly and professionally both verbally and in writing,
• Good MS Office, Veeva, DocuBridge skills,
• Good spoken and excellent written English Knowledge of any other European language would be an advantage,
• Knowledge of, and understanding of ICH guidelines (Quality), GMP requirements, Regulatory procedures (US-FDA, EU-CHMP, and others such as Health Canada, Swissmedic, Japanese PMDA, Chinese FDA),
• Advance knowledge of drug substance and/or Drug Product development, manufacturing process, quality control, packaging activities and regulatory environment.