Senior Regional Regulatory Affairs Specialist - APAC

at  Oxitec

Oxitec is seeking a talented Senior Regional Regulatory Affairs Specialist to join our Regulatory Affairs Team. This role requires a professional with in-depth knowledge of regulatory legislation in APAC regions and the ability to provide expert guidance in this field.
The ideal candidate will have prior regulatory experience, preferably involving GMOs, pesticides, or biological control products such as Wolbachia, and a strong understanding of regulatory frameworks in key APAC markets will be critical. We are looking for motivated and initiative-taking individuals who can confidently deliver regulatory advice and support Oxitec’s mission and business goals, ensuring full compliance and statutory requirements.
At Oxitec, we value an open, inclusive, and collaborative culture. Diversity is at the heart of who we are, and we welcome applicants from all backgrounds. If this opportunity excites you, we would love to hear from you!

ABOUT US

We are a team of passionate individuals, developing ground-breaking biological technologies designed to sustainably, and safely control pests that transmit disease, destroy crops and harm livestock. We do this work to improve lives and livelihoods around the world in the face of the growing threats that pests pose to human health and the global food supply.
Whilst what we do relates to developing pest control technologies, Oxitec is about people and is in service to people.
We are strongly committed to a set of values, principles, and behaviours, and foster a culture of trust, respect, creativity, and accountability. Click here to learn more, and here to read our CEO’s blog about trust and our culture.

SKILLS, EXPERIENCE, AND EDUCATION REQUIREMENTS

(E) Essential

• A BSc in biological or life sciences, entomology, regulatory affairs or similar.
• 5+ years of experience in regulatory affairs, gained in APAC regions.
• Proven experience in handling regulatory submissions and approvals in these markets.
• In-depth understanding of regulatory frameworks and requirements in APAC, specifically legal frameworks in regulating GMOs, biological insect control, trial authorisations, licensing, and lifecycle management. (E)
• Proven experience of achieving successful regulatory approvals and successful interactions with regulatory agencies. (E)
• Familiarity with relevant international guidelines.
• Excellent project management and organisational skills.
• Excellent use of written and verbal communication skills in English, additional language skills relevant to APAC regions are a plus (additionally, Spanish would be desirable). (E)
• Demonstrate good analytical, investigative, and problem-solving skills, with the ability to interpret data. (E)
• Detail-oriented, proactive, and able to manage multiple projects simultaneously.
• Strong interpersonal and collaboration skills, with the ability to work across cultures and time zones, and ability to build and develop relationships at all levels within business. (E)
• Proficiency in Microsoft business applications (Office suite, Teams, and SharePoint, OneDrive) as well as willingness to familiarise autonomously with specific regulatory information systems and tools. (E)
• Availability to travel through the region or to Oxitec’s Head Office when required (E).

BEHAVIOURAL REQUIREMENTS

• Committed to and passionate about Oxitec’s mission and values.
• Responsive to the needs of an international business working across different time zones, adapting working patterns in-line with business requirements.
• Positive, humble, co-operative, and professional always.
• Work with a sense of urgency and solve things promptly.
• Adaptable and persistent in an innovative and constantly changing environment.

PURPOSE OF THE JOB

The Senior Regional Regulatory Affairs Specialist will play a critical role in managing and executing regulatory strategies to ensure Oxitec’s products receive regulatory registration and commercial approvals in diverse markets across Asia-Pacific (APAC).
It will be essential to possess advanced knowledge and expertise in the regulatory requirements governing biological products, including genetically modified organisms (GMOs) and innovative technologies such as Wolbachia-based vector control solutions. The role requires a deep understanding of the scientific, ethical, and regulatory considerations associated with these products, as well as the ability to navigate complex approval pathways to diverse regulatory environments, particularly in the APAC region. This includes ensuring compliance with biosafety regulations, risk assessment protocols, and environmental release guidelines while collaborating with internal R&D teams and external regulatory authorities to achieve timely approvals. Individuals in this role must be adept at addressing emerging challenges in the oversight of novel biological products and fostering relationships with regulators to support shaping of policies and frameworks in these evolving fields.
Responsibilities may include, but are not limited to, investigating, examining, and evaluating legislation and regulatory frameworks for APAC regions, as well as preparing dossiers and regulatory submission documentation to the regulatory authorities. Our new team member may also conduct compliance and enforcement inspections to ensure Oxitec’s products and organisation remain compliant with all key market requirements and that permits are arranged in a timely fashion when requested.
It will be essential to maintain a strong interface with business continuity, including consulting on activities relating to intellectual property, socioeconomic impact studies, lobbying strategies, and legal aspects of business development. Effective project management skills and confidence to ensure clear communication and effective collaboration with cross-functional teams such as internal and overseas external stakeholders is essential.