Vacancy: Director of Regulatory Affairs (Pharmaceutical), Ireland

Acorn Regulatory has been retained by a dynamic Irish pharmaceutical company to recruit a Director of Regulatory Affairs for their expanding facility.  The successful candidate will have the opportunity to utilise their expertise in an entrepreneurial setting and to contribute to the growth of the company.  The company has a portfolio of successful products that are available on markets throughout the world.  

The clients business has an international focus and the role would suit an experienced regulatory professional seeking a new challenge.  Details of the role are as follows:

Responsibilities :

  • Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
  • Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy
  • Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications
  • Provide expert regulatory affairs and regulatory compliance input to in-licensing evaluations and due diligence activities
  • Provide advice about drug regulations to manufacturers/scientists
  • Coordinate successful submissions and approval of all drug applications
  • Ensure that Global Regulatory standards are met and that the deliverables meet strict deadlines
  • Coordinate the writing, review and approval of corporate regulatory and quality procedures according to international GMP regulations and assure that the companies sites are implementing procedures in compliance with the corporate procedures
  • Keep up-to-date with changes in regulatory legislation and guidelines
  • Write and or review comprehensible, user-friendly, clear product information leaflets and labels
  • Liaise, negotiate and arrange meetings with regulatory authorities as needed to support the company’s regulatory strategy
  • Develop and establish policies and standards that convey the best practices in the company
  • Project management to support development of new generic products

Requirements, Skills, Experience:

  • BSc/MSc degree
  • Minimum of 5 years’ experience managing a regulatory team for a pharmaceutical company in the US or EU
  • Deep experience from pharmaceutical industry from a regulatory affairs perspective
  • Knowledge of USA and European pharmaceutical legislation, relevant guidelines – including ICH, procedures and requirements
  • Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance
  • Ability to develop innovative strategies and creative solutions within the regulatory context and within the scope of global requirements and available resources
  • Strong initiation and organizational skills
  • Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes
  • Strong analytical skill and technical/ scientific competence
  • Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking “the big picture” view on various optionsTeam-player, able to positively influence team members at all levels with an entrepreneurial “can do” attitude
  • Proactive, quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion
  • Experience from working with generics is an advantage
  • Experience in pharmacovigilance is an advantage
  • Fluent in oral and written English
  • Proficient in use of MS-Office applications (e.g. Excel, PowerPoint, Visio, MS-Project)
  • Ability to travel internationally and work a flexible schedule based on project needs.

If you would like to have an initial confidential discussion about this role then please contact Brian Cleary at Acorn Regulatory.  Email brian.cleary@acornregulatory.com or call 00353 52 61 76 706.