Regulatory Affairs Specialist
hace 1 semana
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pharmalex. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for labeling and regulatory submissions.
Key Responsibilities- Prepare, revise, and compile informative texts for healthcare professionals and patients in the EU and non-EU markets.
- Manage the creation and maintenance of CCDS/CCSI/RSI, collaborating with relevant departments and expert functions.
- Ensure communication with internal and external stakeholders regarding new and updated CCDSs.
- Escalate deviation and compliance issues to labelling governance bodies as necessary.
- Provide regulatory expertise to regulatory programs and projects, as well as to clients.
- General guidance and consultancy on Regulatory Submissions & Labelling activities, including updates on new trends and/or changes in legislation.
- Present seminars and lectures on behalf of Pharmalex internally, for customers, and for professional audiences.
- Create, revise, edit, and maintain regulatory documentation.
- Professional interaction with clients and Health Authorities.
- Coordinate project teams with internal and external staff and Regulatory Alliance Partners on a worldwide level.
- Participate in strategic regulatory issues, including the definition of suitable methods of resolution.
- Provide technical support to business development with a focus on Labeling activities and adjacent areas on EU and global levels.
- Fluent business English or English as a mother tongue, preferably with skills in another EU language.
- Completed degree in pharmacy, medicine, or other life sciences, or a bachelor's degree in science, engineering, or mathematical domain.
- Professional experience in regulatory affairs with a track record in labeling activities for innovator drugs on a global level.
- Sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region.
- Affinity for databases, labeling software tools, and project management software.
- Team player, communicative, conscientious, accurate, and responsible.
- Diverse and challenging job.
- Open and appreciative corporate culture.
- Flexible working hours based on trust.
- Possibility to work reduced number of hours.
- Possibility to work from home.
- Continuous development opportunities through knowledge and experience as well as training.
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