Regulatory Specialist

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $17,000 - $25,000

Job Title: Regulatory Specialist

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Thermo Fisher Scientific is seeking a highly skilled and experienced Regulatory Specialist to join our team. In this role, you will be responsible for managing the preparation, review, and coordination of Country Submissions in line with global submission strategy.

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The successful candidate will have a strong background in regulatory affairs, with experience in preparing and reviewing regulatory submissions, as well as coordinating local regulatory strategies. They will also have excellent communication and interpersonal skills, with the ability to work effectively with internal clients and external partners.

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Key Responsibilities:

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  • Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable)\
  • Provides local regulatory strategy advice to internal clients\
  • Develops and implements local submission strategy\
  • Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities\
  • Acts as a key-contact at country level for all submission-related activities
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Required Skills and Qualifications:

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  • 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\
  • 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
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Benefits:

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  • Competitive remuneration package\
  • Annual incentive plan bonus\
  • Range of employee benefits\
  • Opportunity for career development and growth
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Seniority Level:

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Not Applicable

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Employment Type:

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Full-time

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Job Function:

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Research and Science

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Industries:

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Pharmaceutical Manufacturing and Biotechnology Research

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