The primary function of the Senior Specialist, Regulatory Affairs (RA) is to act as the representative of the regulatory affairs organization to the JAPAC commercial organization for all aspects related to the assigned projects within the Neuroscience, Specialty and Eye Care therapeutic area.
Major Responsibilities:
- Supports JAPAC affiliates and Global Regulatory Affairs in Marketing Authorization (MA) related activities for the assigned projects
- Interfaces with affiliates for the assigned projects, including direct/indirect negotiation with regulatory agencies.
- Implements regulatory strategies for the assigned projects for countries in JAPAC under supervision, in line with area commercial priorities and in collaboration with the Global Regulatory Lead and other RA sub-team colleagues.
- Partners with Intercontinental commercial teams to ensure business needs are met.
- Represents the JAPAC regulatory function at sub-teams to present regulatory requirements and commercial interests on the Global Regulatory Product Team (GRPT) to ensure those are met.
- Represents the JAPAC regulatory function at sub-teams or client group meetings (i.e. commercial, R&D, CMC, etc.) 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 against JAPAC regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps. Ensures effective presentation of data, complete and timely responses.
- Compiles and/or prepares regulatory dossier or documents to fulfil local registration requirements in a timely manner.
- Ensures regulatory compliance for the assigned compounds/products. Implements remediation plan to address identified gaps, if any.
- Supports area regulatory initiatives for JAPAC affiliates.
Requirements
- Min Diploma / Degree in science / Pharmacy or any other related courses
- Min 3 to 4 years of regulatory affairs exp in pharma industry
Interested candidates, please forward your resume to [email protected]
Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)
