Regional Submissions Planner I US MNC I 1-Year Renewable

Location Singapore, Singapore
Discipline Healthcare & Medical
Job Reference TC - 589465_1566556598
Salary S$4000 - S$4500 per month
Consultant Name Tammy Chew Wen Hui
Consultant Email tammy.chew@manpower.com.sg
Consultant Contact No. 62325246
EA License No. 02C3423
Consultant Registration No. R1877573

Regional Submissions Planner

Our client is a US MNC and a giant Pharmaceutical company. They are currently seeking a Regional Submissions Planner to join their team.

The Regulatory Submissions Planner supports the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the whole of the AP region.

As a member of cross-functional team and for the assigned products, her/she manages all operational aspects from submission planning, document retrieval, to submission creation and delivery to Health Authorities.

This position requires a high-level expertise and knowledge of the regulatory landscape across the Asia Pacific region, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).

Primary Activities include but are not limited to:

  • Planning, coordinating and reviewing regulatory submissions with release to Country Operations teams and/or submission to Health
  • Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project
  • Lead Submission Planning Management Teams (SPMT)
  • Work closely with the corresponding Planner based in the HQ (US) on assigned products/projects.
  • Drive the submission assembly and delivery process with the Global Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions as per the agreed timelines.
  • Responsible for accessing and maintaining the regulatory systems and databases to fulfil daily functions.
  • Assist in identifying opportunities to continually improve the efficiency of the submission process and participate in small-scale process improvement
  • Maintain knowledge on the regional regulatory procedures (on internal and external guidelines and standards).

Education Requirements:

  • Bachelors' degree in a Life Science related

Experience and Skills:

  • At least 2 years' experience in the regulatory operations area, regulatory affairs will be an
  • Able to multitask with proven project management capabilities including managing dynamic timelines, interacting and negotiating with others, collaboration skill and excellent follow-up ability
  • Thorough knowledge of regulatory guidelines and procedures within the Asia Pacific Region is
  • Excellent communication skills to manage interactions with colleagues within and outside the department to co-ordinate the regulatory submission for a timely delivery
  • Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external
  • Ability to handle time pressure and the consequence of any delay in timely
  • Affinity to work with complex IT

If you're interested, please do kindly send in your detailed and updated CV to Tammy Chew Wen Hui (R1877573) at tammy.chew@manpower.com.sg and I'll reach out to you for a brief confidential chat.

Thank you!

Tammy Chew Wen Hui EA License No.: 02C3423 Personnel Registration No.: R1877573

Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by ManpowerGroup Singapore for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012. To learn more about ManpowerGroup's Global Privacy Policy, please visit https://www.manpower.com.sg/privacy-policy