Senior Regional Regulatory Affairs Specialist - APAC

Senior Regional Regulatory Affairs Specialist - APAC

Industry:Biotechnology
Location:Oxford, Abingdon, or Remote
Contract Type:Permanent

The Senior Regional Regulatory Affairs Specialist will be responsible for managing regulatory strategies and ensuring that products receive regulatory registration and approvals across the Asia-Pacific (APAC) region. The role requires expertise in the regulatory requirements for biological products, including genetically modified organisms (GMOs) and technologies such as Wolbachia-based vector control. The Specialist will work with internal teams and external authorities to ensure compliance with biosafety, risk assessments, and environmental guidelines, navigating the regulatory landscape across various APAC countries.

Strategic Regulatory Leadership

• Develop and implement regulatory strategies for product registrations and lifecycle management in APAC regions.
• Monitor and analyze regulatory changes and assess their impact on product portfolios.
• Advise stakeholders on regional regulatory requirements during product development, launch, and post-approval.
• Report regulatory risks and strategies to senior leadership.
• Identify opportunities to enhance regulatory processes and improve efficiency.

Regulatory Submissions and Compliance

• Lead regulatory dossier preparation for new products, renewals, and variations in APAC.
• Oversee post-market regulatory activities, including adverse event reporting and product recalls.
• Manage responses to regulatory authority queries.
• Ensure compliance with local, regional, and international regulations.
• Support labeling, packaging, and promotional materials to meet regulatory standards.
• Guide environmental, social, and economic impact studies to ensure compliance with regulations.

Cross-Functional Collaboration

• Work with R&D, commercial teams, and external partners to align regulatory requirements with business objectives.
• Maintain strong relationships with partners and consultants to streamline processes.
• Represent the company in meetings with regulatory agencies and industry associations.
• Track and report on the status of regulatory submissions across multiple countries.
• Ensure compliance during field trials and commercial activities.

Regulatory Documentation and Reporting

• Maintain organized records of regulatory submissions, approvals, and correspondence.
• Prepare regulatory reports and provide updates to internal stakeholders.
• Ensure compliance with KPIs and timelines for regulatory activities.

Audit and Inspection Support

• Assist with regulatory inspections and audits.
• Support corrective actions in response to audit findings.
  
  

Essential

• A BSc in biological sciences, entomology, regulatory affairs, or similar.
• 5+ years of experience in regulatory affairs within the APAC region.
• Proven success in regulatory submissions and approvals in APAC.
• Deep understanding of regulatory frameworks, specifically for GMOs, biological insect control, and licensing.
• Experience in interacting with regulatory agencies to achieve approvals.
• Familiarity with international regulatory guidelines.
• Excellent project management and organizational skills.
• Strong communication skills in English; additional languages, including Spanish, are a plus.
• Analytical, investigative, and problem-solving skills.
• Ability to manage multiple projects simultaneously.
• Proficiency in Microsoft Office, Teams, SharePoint, and regulatory systems.
• Availability to travel within the region as needed.

Behavioral Requirements

• Passionate and committed to the mission and values of the organization.
• Flexible and responsive to the needs of an international business across different time zones.
• Positive, collaborative, and professional in all interactions.
• Ability to work with a sense of urgency and adapt to a dynamic environment.
  
  

£60,000 - £85,000 per annum (depending on experience)

• Tiered pension scheme
• Bonus scheme
• Life assurance
• Lifestyle coaching
• 24hr GP
• Mental health support
• Eye tests

… and much more, please ask for the full benefits package.

If you are interested, please send your CV to .