This is a 6 months, renewable contract.
This position will work within the Global Regulatory Affairs and Clinical Safety organization, in the Regulatory Affairs Operations - Asia Pacific department in Singapore.
This role 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 Authorities.
- Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
- Lead Submission Planning Management Teams (SPMT) meetings.
- 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 projects.
- Maintain knowledge on the regional regulatory procedures (on internal and external guidelines and standards).
- Bachelors degree in a Life Science related discipline.
Experience and Skills:
- At least 2 years' experience in the regulatory operations area, regulatory affairs will be an asset.
- 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 required.
- 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 customers.
- Ability to handle time pressure and the consequence of any delay in timely submissions.
- Affinity to work with complex IT systems.
Please send your resume to me at email@example.com / call me at +65 6232 5246 for more enquiries.
Jasmin Teh Jia Min
Senior Recruitment Consultant
Strategic Client Services
Personnel Reg No.: R1658824
Jasmin, Jia Min Teh EA License No.: 02C3423 Personnel Registration No.: R1658824