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).
- 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 firstname.lastname@example.org and I'll reach out to you for a brief confidential chat.
Tammy Chew Wen Hui EA License No.: 02C3423 Personnel Registration No.: R1877573