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Karen Shiel
Life Science

+353 1 5079256
[email protected]
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Details

Associate Director - Clinical Regulatory Scientist


Reference:KS/AYJD-372542 Location: Cork
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs Director, Regulatory Affairs Manager

Associate Director - Clinical Regulatory Scientist
Our client, a global pharma company are currently recruiting for an Associate Director - Clinical Regulatory Scientist (Specialising in Paediatrics) to join their team and a permanent basis. As Associate Director Clinical Regulatory Scientist you will develop and execute the regulatory strategy for the US and Canadian market. This role offers hybrid working.

Role/ Responsibilities:

  • Develop, Update and Execute US and Canada Registration Strategy
  • Initiate and Update Regulatory Strategy Document
  • Assist or lead in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/HC meetings and regulatory trends. Integrate information from the external environment, product specific regulator advice, and other public information (i.e., Advisory Committees) to develop robust, innovative regulatory strategies
  • Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by the organisation and knowledge of competitor labelling
  • Monitor upcoming and recent approvals of competitive development programs/plans
  • Integrate US/CA regulatory strategy into global registration strategy
  • Partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy
  • Communicate and share key information to enable seamless execution of US/Canada regulatory strategy
  • Provide input to clinical program to support market differentiation needs
  • Communicate the regulatory options and impact on proposed product development plans, seeking Senior Regulatory Scientist and management alignment
  • Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assets
  • Collaborate with internal teams for the success of the pricing and access strategies through influencing what data is needed and how it is collected on development or product lifecycle planning
  • Support development and update of labelling strategy to deliver market differentiation
  • Initiate and update Claims Mapping, and Labelling Dashboard
  • Partner with regulatory, product and clinical development, commercial and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources (e.g., Claims mapping) and network for alignment
  • Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments
  • Use global labelling strategy to influence the drug development strategy
  • Create and communicate labelling dashboard to drive internal alignment on labelling strategy and key risks
  • Develop and Update US and CA labelling, including prescribing information, patient labelling, device labelling (IFU) for new products and indications
  • Support the development of the US/Canadian labelling strategy in collaboration with Senior Regulatory Scientist and project personnel
  • Support strategic development of US/CA labelling documents for initial submission, line extensions, key changes, and key updates, and provide responses to agency labelling questions. Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling
  • Support development of strategy for submission and amendments for: IND, IDE, NDA/BLA, NDS, PMA/510(k), and de novo
  • Determine and communicate submission and approval requirements and regulator expectations
  • Generate regulatory documents for submissions. Ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate the organisations scientific position
  • Anticipate, resolve, and communicate key technical, operational, and strategic issues that may impact other development functions or the development team
  • Propose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems
  • Liaise with product and clinical development team and liaison with diagnostic development experts
  • Provide high quality, timely and decisive regulatory advice that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business development
  • Communicate regulatory risks, potential impact and mitigation plans with development team leadership and regulatory management
  • Cultivate relationships with development teams
Education/ Experience:
  • Bachelor’s degree in scientific or health sciences discipline
  • Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5-8 years
  • Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable
  • Demonstrated deep knowledge of the drug development process, regulatory/business strategies and plans required
  • Demonstrated ability to assess and manage risk in a highly regulated environment
  • Demonstrated strong written, spoken and presentation communication
  • Demonstrated negotiation and influence skills
  • Demonstrated attention to detail
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal ss
For further information please contact: Karen Shiel on 087 745 2487 or send CV to [email protected]