Regulatory Affairs Specialist

1 settimana fa

Milano, Lombardia, Italia PharmaLex A tempo pieno
About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at PharmaLex. As a key member of our team, you will be responsible for managing the preparation and revision of informative texts for healthcare professionals and patients, as well as ensuring compliance with regulatory requirements.

Key Responsibilities
  • Participate in the preparation and revision of SmPCs, PILs, and labelling for EU and non-EU markets, including the development of target product/labelling profiles.
  • Manage the creation and maintenance of CCDS/CCSI/RSI, in collaboration with relevant departments and expert functions.
  • Ensure communication with internal and external stakeholders regarding new and updated CCDSs.
  • Evaluate and 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.
  • Offer guidance and consultancy to PharmaLex staff and customers on Regulatory Submissions & Labelling activities, including updates on new trends and changes in legislation.
  • Present seminars and lectures on behalf of PharmaLex, internally, for customers, and for professional audiences.
  • Develop, revise, edit, and maintain regulatory documentation.
  • Interact professionally 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 the EU level and globally.
Requirements
  • Fluent business English or English as a native language, with proficiency in another EU language.
  • A 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 strong 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 the ability to closely monitor and adhere to timelines.
  • Excellent communication, teamwork, and problem-solving skills.
  • Proficiency in MS Excel, MS Word, databases, and document management systems.
What We Offer
  • A diverse and challenging job with opportunities for growth and development.
  • An open and appreciative corporate culture.
  • Flexible working hours based on trust.
  • The possibility to work a reduced number of hours.
  • The possibility to work from home.
  • Continuous development opportunities through knowledge and experience, as well as training.

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