Manager Regulatory Affairs

An exciting opportunity has arisen for a Senior Regulatory Affairs Manager in Germany. In this role you will be expected to provide regulatory services for European projects for pre and post authorisation submission and maintenance activities.

Job Responsibilities

• Provide primary contact to competent authorities for assigned projects/responsibilities
• Provide regulatory expertise to development, registration and maintenance of pharmaceutical products within assigned projects.
• Develop and maintain regulatory strategy including regulatory intelligence and regulatory risk assessments with focus on European regulatory procedures and requirements
• Work with the document management system (CREDO) per companies rules
• Maintain state-of-the-art knowledge of development in the professional and regulatory environment to be able to provide guidance for timely incorporation to the companies programs
• Provide sound advice and interpretation to the companies employees and Senior Management related to regulatory requirements
• Input of regulatory strategy for product development (incl. PIP, ODD, EU regulatory procedures, scientific advices, etc.)
• Clarification of specific content-related questions for product development (e.g. CMC, non-clinical, clinical)
• Review of key documents (e.g. study protocols, clinical study reporte, Informed Consent Forms, eCTD documents like expert reports, MAA and CTA documentation)
• Preparation and performance of national and international agency communication and meetings
• Submission, conduct and maintenance of relevant designation applications, opinions according to regulatory and or competent authority requirements
• Preparation and release of Marketing Authorisation submission dossiers (new applications and line extensions)

Skills and Requirements

• Degree in Medicine, Pharmacy, Life Sciences or Chemistry
• Several years of clinical/industry/health authority or otherwise relevant experience.
• Extensive experience in European Regulatory Affairs encompassing strategic and operational aspects
• Very good communication skills (in English)

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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