Regulatory Affairs Specialist
hace 2 días
Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Montezuma Winery Llc. This is a challenging opportunity for a professional with experience in labeling activities for innovator drugs on a global level.
Key Responsibilities
- Participate in the preparation and revision of informative texts for healthcare professionals and patients in EU and non-EU markets.
- Manage the creation and maintenance of CCDS/CCSI/RSI, as applicable, in collaboration with relevant departments.
- Ensure communication to internal and external stakeholders regarding new and updated CCDSs.
- Escalate deviation and compliance issues to the labelling governance bodies as necessary.
- Provide regulatory expertise to regulatory programs and projects, as well as to clients.
- General guidance of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities.
- Present seminars and lectures on behalf of PharmaLex internally, for customers, and for professional audiences.
- Creation, revision, editing, and maintenance of regulatory documentation.
- Professional interaction with clients and Health Authorities.
- Coordination of project teams with internal and external staff and Regulatory Alliance Partners on a worldwide level.
- Participation in strategic regulatory issues, including definition of suitable methods of resolution.
- Technical support to business development with particular focus on Labeling activities and adjacent areas on EU level and preferably also on global level.
Requirements
- Fluent business English or English as 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 profound track record in labeling activities for innovator drugs on a global level.
- Experience in handling marketing authorizations and their lifecycle management.
- 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, with ability to closely monitor and adhere to timelines.
- Team player, communicative, conscientious, accurate, and responsible.
- Confident with MS Excel and MS Word, as well as databases and document management systems.
What We Offer
- 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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