Director / Head, Regulatory Affairs (Clinical Trials) - Mandarin speaking
This is a regular Job Posting
Working Place: Remote Reporting
Office Address: APAC - fully remote
Job Type: Full-time (Remote)
Industry & Field: Biotechnology/Life Sciences, Health Care
Phone Number: +61 (0) 37 068 9299
Contact Name: www.planet-pharma.com
Refresh Date: Sep. 2, 2025
Expiration Date: Nov. 2, 2025 Expired
SUMMARY
Our client is a medium size Global CRO with a very strong presence worldwide. They have had a huge amount of success in the biotech space and are now expanding their RA function in Asia and are seeking a Mandarin speaking Head of Regulatory Affairs to lead their function.
This role will carry line management responsibilities with the opportunity to build and shape the regulatory team from scratch!
RESPONSIBILITIES
Lead regulatory strategy and operations for global submissions (e.g., IND/CTA, amendments, orphan designations, expedited pathways).
Provide expert guidance on clinical development, regulatory standards, and ICH/GCP compliance.
Manage and mentor Regulatory Managers; oversee resource allocation and performance.
Represent Regulatory Affairs in cross-functional and client-facing meetings.
Ensure regulatory documentation meets quality and compliance standards.
Support audits, policy development, and implementation of regulatory tools.
Maintain expertise in international regulations and assess emerging requirements.
Contribute to business development through proposal generation and strategic input.
DURATION
Full-time, permanent
SALARY
Attractive salary + benefits
LOCATION
APAC - fully remote
ABOUT PLANET PHARMA
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
TO APPLY
Please click ‘apply’ or contact Sam Chapple (Associate Director, Recruitment - APAC) at Planet Pharma for more information:
E: ***@***.***
T: : +61 (0) 37 068 9299
Linkedin: https://www.linkedin.com/in/sam-chapple-42b459131/
Qualifications & Requirements:
Required:
Bachelor’s or postgraduate degree in science or healthcare.
10+ years in regulatory affairs within CRO, pharma, or biotech.
Deep knowledge of global regulatory frameworks (FDA, EMA, APAC, ICH/GCP/GMP).
Proven leadership in regulatory strategy and clinical program management.
Fluent in English and Mandarin; proficient in MS Office.
Preferred:
Advanced degree (MD, PhD, PharmD) or RAC certification.
Experience in financial oversight and team leadership.
Core Competencies
Strong communicator with excellent presentation and interpersonal skills.
Skilled in managing complex projects and cross-functional teams.
High integrity, strategic mindset, and results-driven approach.
Ability to influence, delegate, and foster collaborative environments.
Comfortable with ambiguity and capable of sound decision-making.
Founded in 2012, Planet Pharma is a global leader in life sciences recruitment and staffing, specializing in Pharmaceuticals, Biotechnology, Medical Device, Labs & Healthcare, Specialty Providers, CMOs / CDMOs, and Contract Research Organizations (CROs). We provide the following solutions: Contract & Direct Hire (Permanent) Staffing, Strategic Resourcing, Retained & Executive Search, Functional Service Provider (FSP), and Global Workforce Solutions.
Planet Pharma has offices throughout North America, Europe, and APAC. All locations operate with shared attributes at the heart of everything we do!
🚨 Job Scam Warning 🚨
We’ve recently been made aware of fraudulent activity where individuals are posing as representatives of Planet Pharma and contacting job seekers using fake email addresses.
✅ All genuine emails from Planet Pharma will always come from an address ending in @planet-pharma.com, @planet-pharma.co.uk, or @ppgadvisorypartners.com.
❌ We will never contact you from free email services or unfamiliar domains.
If you receive a message claiming to be from us and are unsure if it’s legitimate, reach out to us directly at ***@***.*** for verification. Your safety and trust are our priority!
Website
http://www.planet-pharma.com
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