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Regulatory Affairs Senior Officer

2 weeks ago

Athens, Attica, Greece VERISFIELD Full time €60,000 - €80,000 per year
About UsThe RoleKey Responsibilities
  • Prepare, review, and coordinate CMC sections (Modules 2.3 and 3) of technical dossiers for new product submissions
  • Evaluate existing dossiers to ensure compliance with the latest EU and international regulatory guidelines
  • Lead the preparation of quality variations and responses to regulatory authorities
  • Liaise with internal stakeholders, contract manufacturers, and suppliers to gather and verify required documentation
  • Perform gap analyses and propose strategies to address deficiencies
  • Provide guidance and technical support to junior Regulatory Affairs Officers
  • Contribute to the development of departmental SOPs and maintain up-to-date regulatory databases
  • Stay current with global regulatory changes relevant to pharmaceutical quality and CMC submissions
Candidate Profile
  • University degree in Pharmacy, Chemistry, Biology, or a related field
  • Minimum of 4 years of experience in Regulatory Affairs with a focus on CMC; 6 years or more is desirable
  • Professional experience in the Pharmaceutical Industry, in R&D, QC, or other related areas with strong CMC exposure will also be considered
  • Solid understanding of pharmaceutical quality standards and regulatory requirements
  • Strong attention to detail, organizational, and analytical skills
  • Excellent command of the English language and strong computer literacy
  • Experience mentoring or guiding junior colleagues is a plus
What We Offer
  • Competitive compensation and benefits package, including health insurance
  • Clear opportunities for career advancement and professional growth
  • A collaborative and forward-thinking work culture
  • The chance to be part of a team that brings innovative medicines to patients globally
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