Global Regulatory Affairs Specialist

3 days ago

Singapore beBeeRegulatory Full time

Regulatory Affairs Professional

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This role is responsible for managing all domestic and regional regulatory affairs, including but not limited to new drug applications (NDAs), variations, and registration renewals in Singapore and Asian countries.
\\[This professional will also be responsible for establishing pharmacovigilance systems for the company's products. \]\

  • The main responsibilities of this position include preparation and documentation of regulatory submissions to government agencies.
  • Responsibilities involve working on complex problems where analysis of situations or data requires a review of identifiable factors.
  • The incumbent must exercise judgment within defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Generally receives no instructions on routine work, general instructions on new assignments.
  • May provide leadership by assigning work and resolving complex problems.
  • With direction, develops plans for regulatory strategies. Participates in project team meetings and provides regulatory advice. Seeks solutions and alternatives to problems and issues.
  • Prepares regulatory documents for regional submissions. Acquires information from appropriate technical groups and project personnel which addresses performance of diagnostic reagents, instruments, and software. Assures adequate documentation exists for product claims and directs timely review of regulatory documents.
  • Acts as liaison for international divisions by tracking requests for information and monitoring international laws. Provides product performance data as requested by international personnel and other corporate groups.
  • Monitors FDA and other agency laws and regulations, and provides recommendations and assistance to ensure company compliance.
  • Directs certification application activities including sending and tracking certification letters. Maintain tracking log, and supply global registration requests.
  • Provides metrics for regulatory management reporting and helps to identify areas for further monitoring for global product development system (GPDS) improvements.
  • Track global registration status for project teams and new products. Log, track, and prepare report from eGPS system.
  • Brings Regulatory Affairs questions/issues to the attention of RA management.
  • Preparing responses to agency's questions with good writing and communication skills.
  • Performs other related duties and assignments as required.
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Required Skills and Qualifications:

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  • Minimum degree in any science-related field.
  • Minimum 2-3 years of experience in either domestic and regional regulatory affairs would have an advantage.
  • Familiar with regulatory affairs such as NDA, variation, and renewal of product registrations in Pharmaceutical industry (manufacturer or distributor) would be at an advantage.
  • Pharmacovigilance (or safety monitoring/reporting) experiences preferred but not mandatory.
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Benefits:

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  • Detail-mindset, responsible, well-organized
  • Strong communication and interpersonal skill in shared office environment.
  • Pro-active and positive mindset
  • Able to Prioritize tasks and workload
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Other Information:

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If you are interested in this position, please submit your most updated resume to the designated contact.

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