senior regulatory affairs specialist in Singapore

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job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
reference number
91M0124224_1535708381
contact
jin quan jonathan soh, randstad
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job description

Job Description

  • The Senior Regulatory Specialist will be responsible for the following areas:
    • Project Management : Co-ordination, prioritization and tracking regulatory deliverables and submissions associated with the company’s clinical trials for a variety of therapeutic areas.
    • Regulatory Support : Preparation of regulatory applications, under guidance of direct manager, associated with the company’s clinical trials for a variety of therapeutic areas and submissions to authorities.
  • Work closely within the Regulatory department to prepare robust regulatory applications to achieve departmental and organizational objectives.
  • Provide regulatory support to other departments.
  • Identifies and documents all regulatory project deliverables from each functional area by project for global regulatory submissions.
  • Ensures product specific regulatory strategies are documented, maintained, updated, kept on schedule and proactively communicated.
  • Helps facilitate product specific regulatory meetings and functional sub-teams by preparing meeting schedules, agenda, minutes, action items list, Gantt charts and timelines etc.
  • Works closely with the regulatory team and project team to identify and mitigate risks to meeting regulatory submission goals, address any delays and escalates when necessary.
  • Maintain current knowledge of global regulatory

Requirements

  • Bachelor’s degree, preferably in a science related field.
  • At least 3 years of experience in the Biopharma industry preferably with experience in regulatory
  • Demonstrated ability to work in a team environment to develop, implement and deliver on project goals.
  • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills
  • Possess a “can do” attitude
  • Operates effectively in a smaller company and works well across teams within a matrixed organization.
  • Good knowledge of Regulatory Agency regulations, guidelines, and/or specifications (e.g., Asia, FDA, ICH, etc) preferred
  • Good understanding of the overall product development process
  • Strong knowledge with MS Office applications, MS Project, SharePoint and Document Management System.
  • PMP certification is highly desired

Interested and suitable applicants click on the 'Apply Now' button or email Jonathan at jonathan.soh @randstad.com.sg



skills

regulatory affairs

qualification

-

educational requirements

Bachelor Degree