(temporary replacement during 12 months due to parental leave)
The International Regulatory Affairs Manager is responsible within Avextra Pharma GmbH for the compilation of regulatory documents for new products. To this end, the International Regulatory Affairs Manager collaborates on all measures necessary to obtain approval from international authorities for the development, manufacture, marketing, and distribution of the products. It is the responsibility of the International Regulatory Affairs Manager to demonstrate the safety, quality and efficacy of products to various international regulatory authorities and to demonstrate that international regulations, procedural guidelines and principles are being followed.
Tasks and responsabilities:
- Acquire comprehensive knowledge and understanding of regulatory affairs regulations, policies and procedures.
- Ensure appropriate regulatory compliance.
- Compile and maintain databases and systems for regulatory documentation.
- Creation and revision of regulatory documents/CTD (Common Technical Document).
- Support to external clients for the submission of product registration internationally.
- Develop and update required documentation for clinical studies.
- Support the submission for Clinical Studies and Marketing Authorizations.
- Support and advise on regulatory processes and compliance issues.
- Oversee the planning, coordination and management of regulatory documents.
- Review, identify and interpretate relevant regulatory guidance, laws and regulations that have an impact on the company activities.
- University degree in natural sciences or comparable qualification.
- +3 years of professional experience in the regulatory field (preferably within the pharmaceutical industry).
- Knowledge of CTD preparation and maintenance.
- Knowledge of CTIS management (preferably).
- Ability to work to deadlines and successfully prioritize numerous projects simultaneously.
- An in-depth understanding and experience of EU regulatory requirements including marketing authorization submissions and maintenance activities on a European level.
- Ability to manage complex projects and timelines in a matrix team environment.
- Very good written and spoken English skills.
- Team spirit, communication and problem-solving skills, reliability, and an independent way of working.