Job Summary
- Supporting and lead regulatory activities across the Asia & Arab region (excluding China &Japan). This role requires sound regulatory judgment, ability to provide professional advice, and support in developing regulatory strategies in the region.
- Independently, manage more complex regulatory tasks, provide guidance to local company representatives(Responsible Persons), support early dialogues with authorities, and contribute to risk assessment and mitigation planning.
Key Accountabilities
1. Regional Regulatory Strategy & Professional Advice:
- Provide professional advice on complex regulatory matters, including pathway expectations, data requirements, and regulatory classifications.
- Support the development of regional regulatory strategies for new product registrations, renewals, and significant post approval changes.
- Anticipate regulatory risks and challenges, offering strategic recommendations to optimize approval timelines and compliance outcomes.
2. Regulatory Coordination & Lifecycle Management
- Lead coordination with local companies and Responsible Persons for submissions, product registrations, renewals, and lifecycle management activities.
- Review and validate regulatory documentation (e.g., ASEAN CTD, eCTD modules) prepared for local partners, ensuring completeness and alignment with market requirements.
- Oversee the preparation of post approval change applications, ensuring regulatory robustness and timely execution.
3. Health Authority Interaction Support
- Provide professional support for inquiries and preliminary consultations with local Health Authorities, including preparation of scientific justifications and briefing materials.
- Work closely with Responsible Persons to ensure consistent regulatory positions and high quality responses to HA queries.
4. Training & Development
- Provide training and technical support to local Responsible Persons & other internal functional teams on regional regulatory processes.
- Develop and refine templates, training materials, and guidance documents to enhance regulatory capability across the region.
5. Regulatory Intelligence & Research
- Conduct in depth research and analysis on regulatory updates and emerging trends in the region.
- Share insights through presentations during team meetings to support strategic decision making.
- Monitor evolving regulations and assess potential impacts on products, submissions, and business operations
6. Regulatory Risk Assessment & Mitigation
- Perform regulatory risk assessments for new submissions and variations and monitor risk throughout the progress of the applications.
- Identify potential regulatory challenges early and propose actionable countermeasures and mitigation strategies to reduce regulatory exposure and ensure business continuity.
7. Cross-Functional & Regional Collaboration
- Collaborate with internal stakeholders as well as cross-functional teams including Business, Quality Assurance and Pharmacovigilance to ensure alignment of regulatory requirements.
- Act as a regional regulatory subject matter resource for internal teams, offering clarity on RA internal processes
- Foster effective communication between global, regional, and local regulatory teams.
8. Documentation & Systems:
- Support local companies and their designated Responsible Persons to ensure accurate and timely maintenance of regulatory records, correspondence, approvals, and commitments within electronic systems.
- Support continuous improvement of regulatory documentation practices and tools.
Qualifications / Required
Required
- Asia Regional Regulatory operational experience: more than 3 years
- Proficiency in Chinese, Japanese, and Korean to support effective communication with regional regulatory authorities and local teams
- Self-motivated and proactive (high initiative)
- Strong communication/negotiation skills
Preferred
