Regulatory Affairs (FDA） - Bukit Batok

placeBukit Batok scheduleFull-time calendar_month18/3/25

Key Responsibilities

Regulatory Strategy Develop and implement regulatory strategies for U.S. drug approvals (IND, NDA, etc.) in alignment with company objectives.

Provide expert advice on FDA regulations, guidance documents, and best practices to cross-functional teams (R&D, Clinical, Quality, Manufacturing).

Submission Management Prepare, review, and submit high-quality regulatory documents (e.g., INDs, NDAs, amendments, supplements) in compliance with FDA requirements.

Coordinate with internal teams and external partners (CROs, consultants) to gather data and documentation needed for timely submissions.

Regulatory Intelligence & Compliance Monitor and interpret changes in U.S. regulatory requirements and communicate their impact to relevant stakeholders.

Ensure ongoing compliance with FDA regulations throughout the drug development lifecycle, including labeling, advertising/promotion, and post-marketing surveillance.

Cross-Functional CollaborationCollaborate with clinical, nonclinical, and manufacturing teams to ensure regulatory requirements are met at each stage of development.

Provide strategic input during product development to optimize regulatory pathways and expedite approvals.

Agency LiaisonServe as the primary contact for FDA interactions, including meetings, teleconferences, and written communications.

Lead the preparation of meeting packages and presentations; coordinate responses to FDA inquiries and requests.

Documentation & Record-KeepingMaintain accurate and organized records of regulatory communications, submissions, and approvals.

Establish internal SOPs and best practices to streamline regulatory processes.

Qualifications

Education: Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field (advanced degree preferred).
Experience:Minimum of 10 years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.

Proven track record in preparing and submitting FDA regulatory filings (IND, NDA, etc.).

Technical Skills:Strong knowledge of FDA regulations (21 CFR), ICH guidelines, and relevant U.S. regulatory requirements.

Proficiency in regulatory submission software and document management systems.

Soft Skills:Excellent communication skills, both written and verbal, for clear interaction with regulatory agencies and cross-functional teams.

Strong project management and organizational skills, with the ability to handle multiple projects and deadlines.

Detail-oriented and proactive in identifying and resolving regulatory issues.

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