Recruit Express Pte Ltd. | 1 year contract Pharma MNC Senior RA Specialist

3 days ago


Singapore Recruit Express Pte Ltd. Full time

1 year contract Pharma MNC Senior RA Specialist – west (up to 7.4k) #HAN
Singapore | Posted: Dec 30, 2024
Responsibilities:
Supports affiliates and Global Regulatory Affairs in 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 under supervision, in line with area commercial priorities and in collaboration with the Global Regulatory Lead and other RA sub-team colleagues.
Partners with commercial teams to ensure business needs are met.
Represents the 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 regulatory function at sub-teams or client group meetings 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 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 fulfill 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 affiliates.
Requirements:
Minimum Degree in Pharmacy or equivalent.
Minimum 5-8 years of working experience in relevant field.
Interested candidates please send a copy of your resume in MS Word to:
EA Personnel: Alvin Lee Peck Keong
CEI No.: R1104781
Recruit Express Pte Ltd, EA License No.: 99C4599
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