Regulatory Affairs Director/Snr Director

Job Description

A hugely lucrative Senior Regulatory Affairs role has presented itself in the Dublin Market. This is an exciting opportunity to join "HIV and Emerging Viruses" Regulatory Affairs function.

In this role you will provide global regulatory strategic and technical leadership of regulatory activities for paediatric product development. The Dublin site, where this role is based, is their Global Centre of Excellence for said work.

The level of the role is dependant on the experience of applicants however there is significant room for professional growth. This role will report into the Executive Director (based in the US).

Specific Education & Experience Requirements:

• Extensive experience in Regulatory Affairs - Manufacturing and consultancy backgrounds within Pharma/Biopharma/Clinical Trials will be considered
• Paediatric drug development experience is required
• Experience dealing with the US and EU Regulatory bodies

Specific Job Responsibilities:

• 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 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 paediatric 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 paediatric 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 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.
• 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.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.