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Details

Senior Director, Regulatory Affairs (Biopharma)


Reference:KS/AFLG-618530 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Our client is a research-based biopharmaceutical company. They deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

Their worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Their scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.

This is an exciting opportunity to join HIV and Emerging Viruses Regulatory Affairs where you will provide global regulatory strategic and technical leadership of regulatory activities for paediatric product development.

Role/ 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.

Education/Experience:

  • Extensive experience 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 required

For further details please contact Karen Shiel on 087 7452487 or send CV in confidence to karen.shiel@lifescience.ie