Are you an experienced regulatory affairs professional looking to make a global impact? Worldwide Clinical Trials, a leading midsize Contract Research Organization (CRO), is hiring a Senior Regulatory Affairs Manager for a fully remote role in the APAC region. This is an exciting opportunity to join a dynamic team of over 3,500 experts dedicated to advancing clinical research and improving lives through innovative medical solutions. If you excel in regulatory strategy, cross-cultural communication, and leadership, this role is for you. Apply today to shape the future of clinical trials in Asia Pacific!
Responsibilities
As a Senior Regulatory Affairs Manager at Worldwide Clinical Trials, you will play a pivotal role in ensuring compliance and driving regulatory success across the APAC region. Your key responsibilities include:
- Regulatory Submissions: Coordinate and manage regulatory and ethics committee submissions across EMEA, Asia Pacific, and Latin America, ensuring timely approvals and compliance with global standards like ICH GCP.
- Contract Negotiation: Review study budgets and costing to support contract negotiations, ensuring alignment with business objectives.
- Business Development: Prepare regulatory sections of proposals and feasibility reports, attend bid defense meetings, and contribute to business growth.
- Documentation and Compliance: Prepare and review technical documentation (e.g., IMPDs, IBs) to meet country-specific regulatory requirements.
- Communication: Provide clear updates on submission statuses to sponsors, project managers, CRAs, and Medical & Scientific Affairs staff.
- Mentorship: Train, coach, and mentor junior staff, with potential line management responsibilities.
- Strategic Guidance: Offer expert regulatory advice and contribute to project work to ensure successful trial outcomes.
Qualifications
To succeed in this role, candidates must demonstrate a strong background in regulatory affairs or clinical start-up within the pharmaceutical or CRO industry. Key qualifications include:
- Education:
- A four-year degree in medical, biological, physical, health, pharmacy, or related sciences, OR
- A two-year degree (e.g., nursing or life sciences) with eight years of clinical research experience (e.g., CRA, Regulatory Affairs).
- Experience: Minimum 5 years in the pharmaceutical/CRO industry, with senior-level regulatory or clinical start-up experience in the APAC region.
- Skills:
- Proven leadership and organizational management abilities.
- Strong planning, strategizing, and multitasking skills in a fast-paced environment.
- Excellent written and verbal communication, with proficiency in cross-cultural communication and fluent English (spoken and written).
- Comfort supporting business development in face-to-face settings.
- Attributes: Ability to thrive in a deadline-oriented, dynamic environment with strong interpersonal and relationship-building skills.
Benefits
Joining Worldwide Clinical Trials offers a range of benefits designed to support your professional growth and personal well-being:
- Remote Work: Enjoy the flexibility of a fully remote role, with opportunities to work from Singapore, Taiwan, or India.
- Global Impact: Contribute to groundbreaking clinical trials that improve patient lives worldwide.
- Inclusive Culture: Work in a diverse, collaborative environment that values creativity and innovation.
- Career Development: Access training, mentorship, and leadership opportunities to advance your career.
- Supportive Team: Collaborate with a global team of experts committed to excellence.
How to Apply
