Global Regulatory Compliance Coordinator

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $17,000 - $25,000
Country Regulatory Specialist RoleJob Description:

This is a key position that plays a critical role in the preparation, review and coordination of country submissions.

  • The Country Regulatory Specialist prepares, reviews and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with global submission strategy.
  • They provide local regulatory strategy advice to internal clients, developing and implementing local submission strategies as needed.
  • The specialist serves as primary contact for investigators and with the local regulatory authorities to ensure submissions are managed in a timely manner.
  • They ensure 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.
  • Country Regulatory Specialists act as key-contacts at country level for all submission-related activities.
  • They participate in Submission Team Meetings, Review Meetings and Project Team meetings as required.
  • These specialists coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines.
  • They achieve PPD's target cycle times for site activations.
  • Country Regulatory Specialists prepare the regulatory compliance review packages as applicable.
  • They liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
  • Developing country specific Patient Information Sheet/Informed Consent form documents is also part of their duties.
  • May assist with grant budgets negotiations with sites.
  • Assists in identifying and recognising local out of scope activities in a contract in a timely manner and advise relevant functions.
  • Supports the coordination of feasibility activities as required in accordance with agreed timelines.
  • Ensures trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
  • Oversees country study files ensuring they meet PPD WPD's or client SOP's.
  • Maintains knowledge of and understand PPD SOPs Client SOPs/directives and current regulatory guidelines as applicable to services provided.
  • Directs other SIA individuals assigned to support projects of responsibility as appropriate.
Requirements:
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
  • Previous relevant study start up experience provides the knowledge skills and abilities to perform the job comparable to 3+ years.
  • Therapeutic experience in Oncology essential.
  • Phase I experience essential.
Key Skills and Abilities:
  • 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 SIA team members in a positive and effective manner.
  • Excellent team player with teambuilding skills.
  • Basic organisational and planning skills.
  • Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations.

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