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*URGENT* Regulatory Affairs Specialist - Pharma MNC, UP TO $7K #HXY

Private Advertiser

Singapore

On-site

SGD 60,000 - 80,000

Full time

Today
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Job summary

A pharmaceutical company in Singapore is seeking a Regulatory Affairs Specialist to implement regulatory strategies for various projects across Japan and APAC. The candidate should have a minimum of a related Bachelor's degree and at least 3 years of experience in regulatory affairs within pharma MNCs. Immediate availability is preferred. This role offers an opportunity to collaborate with commercial teams and ensure compliance in registration processes.

Qualifications

  • Minimum Degree in related courses preferred.
  • At least 3 years experience in regulatory affairs within pharma MNCs.
  • Ability to start immediately or with short notice.

Responsibilities

  • Implement regulatory strategies for assigned projects.
  • Partner with commercial teams to address business needs.
  • Represent the regulatory function in various meetings.

Skills

Regulatory compliance
Data presentation
Risk assessment

Education

Bachelor's Degree in related field
Job description
  • Implements regulatory strategies for the assigned projects for countries in Japan and APAC

  • Partners with Intercontinental commercial teams to ensure business needs are met.

  • Represents the Japan and APAC regulatory function at sub-teams to present regulatory requirements and commercial interests

  • Represents the JAPAC regulatory function at sub-teams or client group meetings to present regulatory requirements or provide strategic input for the registration of products.

  • Interfaces with Clinical Development as appropriate

  • Assesses scientific data provided by specialist units for registration purposes, identifying gaps and developing mitigation strategies to address gaps

  • Ensures effective presentation of data, complete and timely responses.

  • Ensures regulatory compliance for the assigned compounds/products. Implements remediation plan to address identified gaps, if any.

Requirements:

  • Minimum Degree in related courses and above

  • Prior 3 years of RA experience in pharma MNCs

  • Able to start immediate or within short notice

If you meet the requirements of this role, please email a detailed resume in Word document to Cindy Wong Xinyi

CEI Registration No.: R2095121

Email: cindywong@recruitexpress.com.sg

Tel: 9666 7710

*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

EA License No: 99C4599

EA Personnel No: R2095121

EA Personnel Name: Cindy Wong Xin Yi

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