Country Regulatory Affairs Specialist

4 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $17,000 - $25,000
Regulatory Expertise for Clinical Trials

This role involves overseeing the preparation, review and coordination of country submissions in line with global submission strategies.

Main Responsibilities:

  • Preparation, review and coordination of local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with global submission strategy.
  • Provide regulatory strategy advice to internal clients.
  • Develop and implement local submission strategies. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
  • Serve as primary contact for investigators and with local regulatory authorities to ensure timely management of submissions.
  • Ensure adherence to guidelines and processes for effective internal team communications as well as communications with investigators, and with country regulatory authorities to ensure timely management of submissions.
  • Act as key-contact at country level for all submission-related activities.
  • Participate in Submission Team Meetings, Review Meetings and Project Team meetings.
  • Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are Aligned to the critical path for site activation.
  • Achieve target cycle times for site activations.
  • Prepare regulatory compliance review packages, as applicable.
  • Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
  • Develop country specific Patient Information Sheet/Informed Consent form documents.
  • May assist with grant budgets(s) and payment schedules negotiations with sites.
  • Assist in identifying and recognising local out of scope activities in a contract in a timely manner and advise relevant functions.
  • Support the coordination of feasibility activities, as required, in accordance with agreed timelines.
  • Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
  • Oversee country study files and ensure that they meet PPD WPD's or client SOP's
  • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Direct/mentor other SIA individuals assigned to support projects of responsibility, as appropriate

Required Skills and Qualifications:

  • 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.

Benefits:

  • Opportunity to work on clinical trials projects with a focus on regulatory affairs.
  • Chance to develop and implement local submission strategies.
  • Collaboration with internal departments to ensure successful site start-up activities.
  • Ability to mentor fellow team members in regulatory affairs.

Others:

  • Familiarity with regional/national country regulatory guidelines and EC regulations.
  • Good communication and interpersonal skills.
  • Strong attention to detail and quality of documentation.

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