Regulatory Compliance Manager

hace 5 días

Madrid, Madrid, España Zentiva Group, a.s. A tiempo completo

Join Zentiva Group, a.s. as we seek a Regulatory Compliance Manager to oversee our regulatory initiatives at the national level. This is a pivotal role where you will manage the Regulatory Compliance framework within the country. Your primary responsibilities will encompass:

  • Delivering a proactive and efficient Regulatory service aligned with business goals
  • Facilitating the market introduction of products
  • Ensuring swift interactions with regulatory bodies and gathering competitive insights
  • Collaborating closely with Central Regulatory Affairs on regulatory intelligence and policy matters
  • Guaranteeing timely fulfillment of all regulatory obligations to maintain the registered product portfolio
  • Ensuring compliance with Local Labelling and readiness for inspections
  • Providing support to various departments within Scientific Affairs, including Market Access, Medical, and Pharmacovigilance

Key Responsibilities:

  • Developing and sustaining a thorough understanding of EU and national regulatory frameworks
  • Establishing relationships with local Regulatory Authorities and pertinent organizations
  • Engaging in the formulation and execution of regulatory strategies
  • Preparing high-quality regulatory submissions within specified timelines
  • Monitoring submission progress and addressing any deficiencies raised by regulatory authorities
  • Updating Marketing Authorizations promptly
  • Preparing and reviewing local modifications to ensure legislative compliance
  • Communicating effectively with supply chain and quality assurance teams
  • Identifying compliance challenges and proposing effective solutions
  • Contributing to the development and maintenance of Standard Operating Procedures
  • Efficiently scheduling and prioritizing team tasks
  • Assisting Market Access and Medical functions as required

Skills, Experience & Knowledge Requirements:

  • Degree in Pharmacy
  • Proficiency in English
  • Competence in Microsoft Windows applications
  • Familiarity with National and European legislation and internal regulations
  • Over a decade of relevant experience
  • Strong ethical standards and sense of responsibility
  • Excellent organizational and planning capabilities
  • Effective communication and collaborative skills
  • Proactive and solution-oriented approach

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