Director, Regulatory Affairs (Pediatrics/Infectious Diseases)

Our client is a global Biopharma who are establishing a new Peadiatric Centre of Excellence in Dublin, Ireland. This is an exciting opportunity to lead a Pediatrics Regulatory Affairs function in the area of Infectious Diseases where you will provide global regulatory strategic and technical leadership of regulatory activities for pediatric product development.

Role/Responsibilities:

• Responsible for providing strategic regulatory guidance on the development of global pediatric submissions, including those required in the US and EU.
• Responsible for leading all pediatric-related regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance for pediatric products is 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.
• Represents Regulatory at internal meetings and in conjunction with the local regulatory liaison, at meetings with regulatory authorities.
• Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new pediatric regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.
• Initiates or contributes to local and/or global process improvements which have a significant impact on the business.
• Excellent verbal, written, negotiation and interpersonal communication skills are required.
• Must have extensive knowledge of pediatric 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 pediatric 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.
• Schedules and arranges own activities and those of direct report(s) (if applicable).
• Is recognized as an expert resource for Regulatory Advice in other departments.

• Extensive experience (12+ years) in Regulatory Affairs with BSc/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 essential
• Infectious disease experience is desirable