Senior Regulatory Affairs Officer

On behalf of my client I am actively seeking candidates for the role of Senior Regulatory Affairs Officer.

Role & Responsibilities:

Regulatory

• Review current registration dossier for all marketed products to identify and record dossier completeness, formatting issues, compliance with guidelines / legislation, on-going regulatory issues (pending variations) and outstanding regulatory commitments.
• Ensure timely preparation and compilation of registration dossier for assigned projects in accordance with EU and international standards
• Managing and coordinating various regulatory activities throughout the life cycle of the project / product.
• Maintain assigned products’ Marketing Authorisations via timely variations and renewals submissions and their approvals
• Ensure meeting registration timelines, via timely response to queries from Health Authorities’ and deficiencies as well as via close cooperation with other involved functions and liaison with Regulatory Authorities, where required.
• To contact and liaise directly with Regulatory Agencies as required.
• Provide project-specific Regulatory Strategic advice, technical expertise and coordination oversight for assigned projects.
• Direct / mentor other RA individuals assigned to support projects of responsibility, as appropriate.
• Participate in project launch meetings, review meetings and project team meetings as required.
• Share up-to-date legislation and guidance with RA colleagues as appropriate.
• Build departmental awareness of local regulatory requirements in EU and international markets and provide regulatory advice, guidance and support to all project teams, as required.
• Support compilation of regulatory component of annual product quality reviews.
• Maintain regulatory files / databases in chronological order. Establish and maintain system for tracking changes in documents submitted to agencies or partners.
• Archive the registration documentation according to internal processes; introduce regular updates to internal RA database(s)
• Appropriate planning for prioritization and coordination of activities among functional areas and within Regulatory Affairs, and for timely identification and communication of project/product related concerns to the relevant departments such that same can be addressed in a timely manner.

Education & Experience

• Knowledge, Skills and Abilities

  Ability to act as liaison with other departments

  Bachelor’s Degree in Pharmaceutical discipline with 5+ years of experience in quality and regulatory teams within cosmetic and pharmaceutical manufacturing facilities

  • Attention to detail and quality of documentation
  • Good interpersonal skills
  • Familiar with computers and their applications, eg. Word, Excel, Power Point
  • Effective oral and written communication skills in English language as well as local language where applicable
  • Basic organizational and planning skills
  • Good negotiation skills
  • Ability to work independently with direction
  • Proven ability to work effectively in a team environment
  • Ability to handle multiple projects
  • Analytical and investigative skills
  • Ability to interpret data
  • Good judgement and decision-making skills

• For full details contact Linda at ldunne@thornshaw.com or call 01 2784671

  www.thornshaw.com