We are pleased to be supporting our biotech client with their recruitment of a Senior Manager Clinical Regulatory Affairs (f/m/d), which is a newly created role as part of their growth plans. The role is to be based in the Munich area with hybrid working available.

Key Responsibilities:

• Develop and implement global regulatory strategies for products, including proactive identification of regulatory risks / options and mitigation strategies
• Coordinate with the cross functional teams to fulfil regulatory submissions by assembling, drafting, editing and reviewing
• Collaborate with external contractors and consultants in the execution of clinical regulatory activities
• Write and/or review of regulatory documents required for filing of NDA/MAAs and IND/CTAs, including but not limited to Modules 2.4 – 2.7, Product Information, responses to the Health Authority questions, clinical study protocols and reports, investigator’s brochures, case report forms, informed consent forms and other relevant documents
• Prepare and/or review briefing documents for Health Authority meetings, Orphan Designations Applications and Paediatric Investigation Plans
• Contribute to regulatory due diligence of the preclinical and early clinical data in support of early development projects
• Providing regulatory intelligence to stakeholders by reviewing and evaluating regulations, guidelines, procedures etc.
• Support development of Target Product Profile for assigned development projects
• Liaising closely with the Health Authorities and ensuring the optimum relationship between the regulatory authorities and the Company
• Monitor changes in the regulatory environments and advise on company adaptive responses
• Supporting pricing and reimbursement activities

Background and Qualifications:

• Successfully completed degree in Live Sciences (for example in Chemistry, Biology, Pharmacy or Medicine)
• Ideally minimum 5+ years of regulatory and drug / biologic development experience, ideally in oncology indication
• Keeping up to date with EU and local legislation, guidelines and practices
• Experience in the preparation of regulatory dossiers and submissions to EMA, FDA or other major regulatory authorities. Ideally, experience in preparing and submitting New Drug Applications and Marketing Authorisation Applications through Centralized (CP) and Mutual Recognition Procedures (MRP) and National Procedures
• Experience in writing of regulatory documents, such as briefing packages for scientific advice meetings, product labels (CCDS, US PI, EU SmPC etc.), response documents, PIP/PSPs etc.
• Proven success in global drug regulatory submissions
• Leading the regulatory activities from early development to commercial launch
• Ability to work in a hierarchically flat matrix environment
• Good preclinical and clinical data interpretation / data analysis skills
• Good management, interpersonal, communication, negotiation and problem solving skills
• Fluent in English, both written and spoken