Country Regulatory Specialist

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000

Job Summary:

A Country Regulatory Specialist is required to manage the preparation, review and coordination of country submissions in line with our global submission strategy. This role involves developing and implementing local submission strategies, providing regulatory advice to internal clients, and serving as a primary contact for investigators and local regulatory authorities.

Key Responsibilities:
  • Prepares, reviews and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with our global submission strategy.
  • Provides local regulatory strategy advice to internal clients.
  • Develops and implements local submission strategies.
  • Serves as primary contact for investigators and with the local regulatory authorities to ensure submissions are managed in a timely manner.
  • Ensures guidelines and processes are followed for effective internal communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.

Requirements:

Education and Experience:
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
  • Previous relevant study start up experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).
  • Therapeutic experience in Oncology essential.
  • Phase I experience essential.
Skills and Qualifications:
  • Effective oral and written communication skills.
  • Excellent interpersonal skills.
  • Strong attention to detail and quality of documentation.
  • Good negotiation skills.
  • Good computer skills and the ability to learn appropriate software.
  • Good English language and grammar skills.
  • Good judgment and decision-making skills.
  • Basic medical/therapeutic area and medical terminology knowledge.
  • Ability to work in a team environment or independently, with minimal supervision, as required.
  • Ability to mentor fellow team members in a positive and effective manner.
  • Excellent team player with teambuilding skills.
  • Basic organizational and planning skills.
  • Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations.
Benefits:
  • Competitive remuneration package.
  • Annual incentive plan bonus.
  • Flexible working arrangements.
  • Generous leave policies.
  • Paid volunteer time off.
  • Access to online courses and professional development opportunities.

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