Regulatory Affairs Manager (Pharmaceutical)

OAC Group Limited; Hong Kong; On-site; HKD 900,000 - 1,100,000; Full time

Job summary

OAC Group Limited in Hong Kong seeks a Regulatory Affairs Manager (Pharmaceutical) to lead global regulatory planning and submissions. Reporting to the Head of Regulatory Affairs, you will shape strategy across discovery, preclinical, and clinical programs while aligning filings with development plans.

You will drive eCTD submissions for INDs and CTAs, coordinate meetings with regulators such as FDA, EMA and NMPA, and ensure compliance with ICH and GMP standards, supporting audits and regulatory

Qualifications

• 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.
• Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred.

Responsibilities

• Develop and implement global regulatory strategies across discovery, preclinical, and clinical programs.
• Lead preparation, authoring, and electronic submission (eCTD) of INDs, CTAs, amendments, safety updates and other dossiers.
• Coordinate formal meetings with FDA, EMA, NMPA, and other regulators; prepare briefing materials and interpret feedback for internal teams.
• Ensure adherence to FDA, EMA, NMPA, ICH, GCP/GLP/GMP standards; support audits/inspections and maintain SOPs and policies.

Skills

Regulatory affairs

IND/CTA submissions

FDA/EMA interaction

Regulatory strategy

English communication

Education

Bachelor's degree in life sciences

MSc/PhD/PharmD preferred

Job description

Regulatory Affairs Manager (Pharmaceutical)

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.