Stellendetail

We are currently seeking a Principal Regulatory Affairs Specialist to join our Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career. 

Knowledge, Skills And Abilities

• Excellent command of the English language (written and oral)
• Excellent attention to detail and quality as well as excellent editorial/proofreading skills
• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Capable of working independently and exercising independent judgment to assess company regulatory needs and work with project team members to producing compliant deliverables
• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for medicines authorization;knowledge of ICH and other global regulatory guidelines
• Excellent analytical, investigative and problem-solving skills
• Plan and prioritize product notification/registration
• Prepare and submit regulatory applications to local health authorities and/or distributors
• Maintain active knowledge of product approval status and shepherd registrations throughout the approval process. Provide management team with regular updates on product registration
• Ensure product registrations are reviewed and renewed as required
• Ensure documentation used, questions and answers from authorities and approvals are appropriately filed
• Be the first contact point for local authorities for regulatory queries
• Establish and maintain a good working relationship with regional and divisional RA peers to gain positive and timely support for submission preparation
• Establish and maintain a trusted relationship with local health authorities and/or distributors through regular meetings, discussions, and/or trainings
• Serve as a regulatory consultant to marketing teams
• Complete the mandatory Quality training subject to the defined timeline and ensure compliance with internal Quality system and policy.

Requirements

• Self-starter with 2 years’ experience in RA department
• Fluent written and spoken English
• Applicable regulatory certification required by NAMMDR would be an advantage
• Ability to manage multiple projects and data and strong attention to detail
• Ability to communicate effectively to all levels of organization and distributors/consultants
• Very good knowledge of MS Office
• Bachelor’s or Master's degree in pharmacy, biotechnology, chemistry or other related science or technical field

  By applying your CV to this job, you agree to the processing of personal data, according to the Regulation on the protection of natural persons regarding the processing of personal data. These data are necessary for us to carry out the recruitment process. Only eligible candidates will be invited to the interview, the date of which will be determined by mutual agreement. All applications will be analyzed objectively and in full confidentiality.