Country Regulatory Compliance Specialist

7 days ago

Sydney, New South Wales, Australia beBeeCompliance Full time $17,000 - $25,000
Country Regulatory Compliance Specialist Role Overview

We are seeking an experienced professional to manage country regulatory submissions and provide strategic guidance to internal stakeholders. The successful candidate will be responsible for ensuring compliance with global submission strategies, maintaining effective internal PPD team communications, and coordinating with local regulatory authorities.

Key Responsibilities:
  • Submission Management: Prepare, review, and coordinate local regulatory submissions in alignment with global submission strategy.
  • Regulatory Strategy Advice: Provide local regulatory strategy advice to internal clients.
  • Local Submission Strategy Development: Develop and implement local submission strategies, providing technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
  • Primary Contact: Serve as primary contact for investigators and with the local regulatory authorities to ensure submissions are managed in a timely manner.
  • Guidelines and Processes: Ensure guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
  • Team Collaboration: Act as a key-contact at country level for all submission-related activities, participating in Submission Team Meetings, Review Meetings, and Project Team meetings.
Required Skills and Qualifications:

To be successful in this role, you will need:

  • Education: Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Experience: Previous relevant study start-up experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).
  • Therapeutic Experience: Therapeutic experience in Oncology is essential.
  • Phase I Experience: Phase I experience is also essential.
Skills and Qualifications:

You will need to possess:

  • Communication Skills: Effective oral and written communication skills.
  • Interpersonal Skills: Excellent interpersonal skills.
  • Attention to Detail: Strong attention to detail and quality of documentation.
  • Negotiation Skills: Good negotiation skills.
  • Computer Skills: Good computer skills and the ability to learn appropriate software.
  • Language Skills: Good English language and grammar skills.
  • Judgment and Decision-Making Skills: Good judgment and decision-making skills.
  • Medical Knowledge: Basic medical/therapeutic area and medical terminology knowledge.
  • Teamwork: Ability to work in a team environment or independently, with minimal supervision, as required.
  • Mentoring: Ability to mentor fellow SIA team members in a positive and effective manner.
  • Organizational and Planning Skills: Basic organizational and planning skills.
  • Regulatory Knowledge: Excellent knowledge of all applicable regional/national country regulatory guidelines and EC regulations.

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