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Head of RA

Job description

Head of Regulatory Affairs

Responsibilities
 
  • Direct, control and implement all regulatory activities worldwide and ensure timely and high-quality submissions
  • Define and implement regulatory strategies for products
  • Build the Regulatory structures and organisations globally
  • Lead the RA department consisting of 3 groups and provide leadership and development to these groups
  • Provide input to the regulatory submission strategy for new clinical development programs for early to late-stage developments
  • Establish processes with HQ stakeholders and country organizations to ensure compliant and lean processes for HQ GxP requirements and countries
  • Manage interactions and tight cooperation with EMA, FDA and national authorities and handle queries from regulatory agencies
  • Monitoring of international regulatory requirements and market-specific registration requirements
  • Provide regular updates on the status of all pending applications and planned submissions
  • Participate in regulatory review of potential in-licensing opportunities/participation in regulatory due diligence activities

Your Qualifications and Experience
 
  • Scientific background and 7+ years of experience in Regulatory Affairs in the pharmaceutical or biotech industry at an international level
  • Industry experience in all aspects of regulatory affairs
  • Ability to work in a global environment, individually as well in multi-disciplinary team, and with external partners and regulators
  • Highly developed analytical, problem-solving and consulting skills
  • Strong leadership, influencing and negotiation skills
  • Flexible team member with positive attitude, energy and ability to prioritize projects
  • Excellent communication and presentation skills in English