Regulatory Affairs Specialist (US Pharmaceutical MNC, Regional)

Regulatory Affairs Specialist (US Pharmaceutical MNC, Regional)

Job Description

GENERAL SUMMARY OF ROLE:

This role will be responsible for all the domestic and regional regulatory affairs (RA), including but not limited to NDAs, variations and registration renewals in Singapore and Asian countries. She (or he) shall also be responsible for establishing domestic and regional pharmacovigilance for the products.

Responsibilities:

• Responsible for the preparation and documentation of regulatory submissions to government agencies.
• Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Normally receives no instructions on routine work, general instructions on new assignments.
• May provide leadership by assigning work and resolving complex problems.
• With direction, develops plans for regulatory strategies. Participates in project team meetings and provides regulatory advice. Seeks solutions and alternatives to problems and issues.
• Prepares regulatory documents for regional submissions. Acquires information from appropriate technical groups and project personnel which addresses performance of diagnostic reagents, instruments, and software. Assures adequate documentation exists for product claims and directs timely review of regulatory documents.
• Acts as a liaison for international divisions by tracking requests for information and monitoring international laws. Provides product performance data as requested by international personnel and other corporate groups.
• Monitors FDA and other agency laws and regulations, and provides recommendations and assistance to ensure company compliance.
• Direct certification application activities including sending and tracking certification letters. Maintain tracking log, and supply global registration requests.
• Provides metrics for regulatory management reporting and helps to identify areas for further monitoring for global product development system (GPDS) improvements.
• Track global registration status for project teams and new products. Log, track, and prepare report from eGPS system.
• Brings Regulatory Affairs questions/issues to the attention of RA management.
• Preparing responses to agency's questions with good writing and communication skills.
• Performs other related duties and assignments as required.

EDUCATION AND EXPERIENCE:

• Min Degree in any science related field
• Minimum 2 - 3 years of experience in either domestic and regional regulatory affairs would have an advantage
• Familiar with regulatory affairs such as NDA, variation and renewal of product registrations in Pharmaceutical industry (manufacturer or distributor) would be at an advantage
• Pharmacovigilance (or safety monitoring/reporting) experiences preferred but not mandatory

SKILLS/KNOWLEDGE/ABILITIES/BEHAVIOUR TRAITS:

• Project strong initiatives to establish the operating procedures for a new start-up organization.
• Strong communication and interpersonal skill in shared office environment.
• Pro-active and positive mindset
• Able to Prioritize tasks and workload

If you are interested in the position, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg (Attn: Regulatory Affairs).

Thank You.