Global Regulatory Affairs Manager: Submissions & Strategy

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

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.