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