Regulatory Submission Planner
- Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
- Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.
The Regulatory Submission Planner will work within the company’s Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regional Regulatory Operations Asia Pacific department in Singapore, Asia.
The Regulatory Submission 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.
WHAT YOU WILL DO
As a member of cross-functional team and for the assigned products, her/she will manage all operational aspects for submission planning and execution of Original Marketing Application (OMA) and post-approval regulatory changes.
This position requires a high-level expertise and knowledge of the regulatory landscape across the AP Region (including China), its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).
Responsibilities include, but are not limited to:
· Planning and managing regulatory operation projects from authorization through delivery to country regulatory affairs teams and/or Health Authorities.
· Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
· Lead or participate in cross-functional forums and meetings
· Work closely with the central planner based in the HQ (US) on assigned products/projects.
· Drive the submission assembly and delivery process with the Global and/or Regional 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 (including China) on internal and external guidelines and standards.
WHAT YOU MUST HAVE
To be successful in this role, you will have:
· Bachelor’s degree in a Life Science related discipline.
· At least 4 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 AP region is required and knowledge of submissions in the wider region (including China) is preferable.
· Excellent communication skills to manage interactions with colleagues in a multicultural environment.
· 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.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace
