Ref No: AM17220
Co. Dublin, Ireland
Regulatory Affairs Director - Dublin.
Director, Regulatory Affairs (Paediatric GRL)
This is an exciting opportunity where you will provide global regulatory strategic and technical leadership of regulatory activities for paediatric product development.
In this role your responsibilities will include:
• Responsible for providing strategic regulatory guidance on the development of global paediatric submissions, including those required in the US and EU.
• Responsible for leading all paediatric-related regulatory activities for assigned project(s) and territories.
• Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance for paediatric products are met for assigned product(s) and territories.
• Prepare and/or manage others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
• Represent Regulatory at internal meetings and in conjunction with the local regulatory liaison, at meetings with regulatory authorities.
• Maintain knowledge of highly complex regulatory requirements up to date, contribute to preparation of new paediatric regulatory guidance wherever possible, comment on draft regulatory guidance and communicate changes in regulatory information to project teams and senior management.
• Initiate or contribute to local and/or global process improvements which have a significant impact on the business.
Interested applicants should have:
• Excellent verbal, written, negotiation and interpersonal communication skills are required.
• Must have extensive knowledge of paediatric regulatory requirements, including ICH requirements and regional requirements for assigned territories, and an understanding of current global and regional trends in Regulatory Affairs, and ability to assess the impact of these requirements to the business.
• Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
• Excellent influencing and negotiation skills.
• Must be capable of taking a leadership role in updating and preparing the company for major changes in paediatric legislation in assigned territories, which impact many departments.
• Must be capable of leading one or more teams in preparation of submissions.
• Work is performed under consultative direction towards corporate regulatory goals and objectives.
• Schedule and arrange own activities and those of direct report(s) (if applicable).
• Be recognised as an expert resource for Regulatory Advice in other departments.
Education & Experience Requirements:
• Extensive experience in Regulatory Affairs or other relevant industry experience with BS/BA
• Significant level of experience in Regulatory Affairs or other relevant industry experience with advanced degree
• Degree in a scientific field is preferred
• Paediatric drug development experience is required