Regulatory Specialist
vor 2 Wochen
Your opportunity at an international company in the pharmaceutical industry Our client, a leading company in the pharmaceutical industry, is looking to strengthen its team in Frankfurt am Main and is seeking a full-time Regulatory Specialist (m/f/d) – Pharma / CMC to start as soon as possible. 2 days per week remote work possible 37.5-hour work week with flexible working hours Attractive compensation package Submit your application easily via our online form – we look forward to hearing from you Your responsibilities Review internal procedures to ensure alignment with current regulatory authorizations Analyze operational updates to assess potential regulatory considerations Coordinate regulatory planning and execution at the site level in alignment with broader organizational frameworks Enable cross-functional awareness of global regulatory milestones to support operational readiness Offer strategic input for technological upgrades and process optimizations from a regulatory perspective Support documentation transfer and adaptation efforts for established products across various markets Prepare technical documentation in accordance with regulatory submission standards and language consistency Contribute to global authorization processes by assembling technical content and compliance documentation Oversee the handling of inquiries and follow-up actions related to regulatory submissions Develop formal responses to health authority communications in collaboration with technical teams Maintain alignment between site operations and regulatory functions at regional and global levels Identify and implement opportunities to enhance regulatory workflows and reduce complexity Provide functional expertise during compliance assessments and regulatory inspections Utilize digital platforms to manage documentation and support process development initiatives Qualifications and skills Pharmaceutical background involving laboratory, manufacturing, or analytical control preferred Regulatory CMC experience, ideally between one and five years Understanding of global regulations and awareness of health authority and industry developments advantageous Strategic problem-solving skills for complex technical and regulatory issues Demonstrates initiative, independent decision-making, and forward-thinking Effective communication with internal teams and external stakeholders Familiarity with chemical and biological product types desirable Experience with internal data management and documentation systems required Strong proficiency in both written and spoken German and English highly recommended What you can expect Hybrid work model and flexible working hours Permanent employment contract Transparent opportunity for direct placement with the client Competitive remuneration package, including bonus payments such as holiday and year-end bonuses Well-structured and thorough onboarding process Dedicated personal support throughout the assignment Access to exclusive employee discounts through established partner programs Exposure to leading international companies and corporate environments Contact Your point of contact for this position Eirini Chrysafidou HR Consultant 069-13872922 eirini.chrysafidou@permacon.de Permacon GmbH Mainzer Landstraße 181 60327 Frankfurt
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