Regulatory Affairs Manager (Pharmaceutical)

One Advisors; Hong Kong; On-site; HKD 900,000 - 1,300,000; Full time

Job summary

One Advisors in Hong Kong is seeking a Regulatory Affairs Manager to drive strategic regulatory planning, submissions, regulator interactions, and compliance management across discovery through clinical development.

The ideal candidate has 5+ years in regulatory affairs, experience with early development programs, and a proven track record with IND/CTA submissions, including interactions with US FDA and China NMPA. Fluency in English is required.

Qualifications

• 5+ years of hands-on regulatory affairs in pharma/biopharma.
• Experience with early-stage development programs or first-in-class therapeutics.
• Proven track record with IND/CTA submissions and US FDA/China NMPA interactions.
• Fluent written and spoken English.

Responsibilities

• Develop and implement global regulatory strategies across discovery to clinical programs.
• Lead IND/CTA submissions and ensure timely eCTD documentation.
• Coordinate agency meetings with FDA, EMA, NMPA and other regulators.
• Ensure compliance with FDA/EMA/ICH/GCP/GLP/GMP standards and audit readiness.

Skills

Regulatory affairs

IND/CTA submissions

Global regulatory strategy

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Advanced degree preferred (MSc/PhD/PharmD)

Job description

• A prominent pharmaceutical group with a broad and diversified product portfolio
• Reports to Head of Regulatory Affairs
• Role focused on submission and communication with regulators

Summary

We are partnering with a prestigious pharmaceutical group to recruit a Regulatory Affairs Manager. Reporting to the Head of Regulatory Affairs, this role will focus on strategic planning on regulatory affairs duties, submission, interactions with regulators and compliance management. Candidates having strong experience with earlier stage development especially on application processes will be highly advantageous.

What you will do

Regulatory strategy

• Develop and implement global strategies across discovery, preclinical, and clinical programs.
• Align filings and guidance with corporate development plans while staying current on US, EU, China and APAC requirements.

Regulatory submissions

• Lead preparation, authoring, and electronic submission (eCTD) of INDs, CTAs, amendments, safety updates and other dossiers
• Establish documentation systems and ensure timely archiving.

Agency interactions

• Coordinate formal meetings with FDA, EMA, NMPA, etc.
• Prepare briefing materials, anticipate questions, rehearse responses and interpret feedback for internal teams.
• Partner with preclinical, translational, medical, clinical operations and CMC teams
• Provide regulatory input into study design, product development and manufacturing; manage external consultants.

Compliance and quality

• Ensure adherence to FDA, EMA, NMPA, ICH, GCP/GLP/GMP standards
• Monitor regulatory changes, support audits/inspections and maintain SOPs and policies.
• Assess impact of evolving regulations on programs, recommend mitigation strategies and safeguard audit readiness and regulatory intelligence activities.

What you will bring

Educational background

• Bachelor’s degree in life sciences, pharmacy, or related field with advanced degree (MSc, PhD, PharmD) preferred.

Regulatory affairs experience

• 5+ years of hands‑on regulatory affairs work in pharmaceutical/biopharmaceutical firms, with exposure to both clinical and CMC activities.
• Experience with early‑stage development programs or novel first‑in‑class therapeutics is highly advantageous
• Non-managerial grade candidates possessing relevant experience seeking for career advancement will be considered
• Proven track record participating in IND/CTA and equivalent submissions, with interactions with US FDA and China NMPA being advantageous
• Fluent communication, both written and spoken, in English.