Worldwide Clinical Trials, a leading global CRO, is hiring a Senior Regulatory Affairs Manager – APAC for a remote opportunity across India, Singapore, and Taiwan. This pivotal role focuses on global regulatory submissions, compliance, and leadership in clinical research. If you have over 5 years of regulatory or clinical start-up experience within the APAC region, this is your chance to lead and make an impact in global clinical trials.
🔹 Key Responsibilities
As a Senior Regulatory Affairs Manager, you will:
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- Lead and coordinate regulatory & ethics committee submissions across APAC, EMEA, and LATAM regions.
- Ensure compliance with ICH-GCP and country-specific requirements.
- Review study budgets, contracts, and proposals for regulatory accuracy.
- Provide expert regulatory guidance, including preparation of IMPDs, IBs, and feasibility reports.
- Mentor and train junior regulatory staff; may manage direct reports.
- Collaborate with sponsors, CRAs, project managers, and business development teams.
🔹 Required Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Health, or related fields.
- 5+ years of regulatory affairs or clinical start-up experience in the pharmaceutical/CRO industry.
- Strong knowledge of APAC regulatory frameworks and cross-cultural communication.
- Proven leadership, planning, and organizational skills.
- Excellent written and verbal English communication.
🌟 Why Join Worldwide Clinical Trials?
- Be part of a global CRO with 3,500+ professionals driving innovative clinical solutions.
- Opportunity to work fully remote with global exposure.
- Supportive leadership, inclusive culture, and professional growth opportunities.
- Contribute directly to advancing treatments for some of the world’s most challenging diseases.
📌 Application Process
