Senior Regulatory Affairs Specialist

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Specialist based in Australia. Join a dynamic clinical research environment where regulatory expertise plays a critical role in bringing clinical trials from planning to startup. In this position, you will lead regulatory activities for complex, multinational clinical studies, ensuring submissions meet applicable local and international requirements. You will serve as a key regulatory contact for sponsors and project teams, providing strategic guidance and ensuring the timely delivery of high-quality regulatory documentation. Beyond project execution, you will contribute to process improvements, regulatory intelligence, and the development of junior colleagues. This opportunity is ideal for an experienced regulatory professional who thrives in a collaborative, international setting and enjoys balancing technical precision with project leadership. You will help maintain regulatory compliance while supporting efficient clinical trial operations across multiple regions.

As a Senior Regulatory Affairs Specialist, you will oversee regulatory deliverables and provide technical leadership across assigned clinical research projects. Your main responsibilities will include: Coordinate regulatory timelines, milestones, and deadlines for regulatory authority (RA) and ethics committee (EC) submissions. Lead global and multinational submissions for complex, large-scale clinical trials, ensuring accuracy, consistency, and compliance. Respond to sponsor inquiries regarding regulatory requirements, submission procedures, and country-specific obligations. Advise project teams on regulatory strategy, providing local submission guidance and technical expertise tailored to each study. Prepare and review core and country-specific submission packages, including initial applications, amendments, and notifications. Conduct peer reviews of regulatory documents and submission packages prepared by colleagues to maintain high-quality standards. Develop and review country-specific Informed Consent Forms (ICFs) and ensure alignment with applicable regulatory and ethical requirements. Review essential clinical trial documents and authorize regulatory release before investigational medicinal products are shipped to clinical sites. Develop and review country-specific clinical trial drug labeling to ensure compliance with regional regulations. Participate in project kick-off meetings, client audits, and other project-related discussions as required. Mentor junior team members through coaching, training, workload coordination, and the development of tools and processes that improve daily operations. Support regulatory country intelligence activities and contribute to special projects, training initiatives, and continuous process improvement. Requirements The ideal candidate combines a strong scientific background with hands-on clinical regulatory affairs experience and the ability to lead complex submissions across multiple jurisdictions. You should demonstrate sound regulatory judgment, excellent communication skills, and the organizational capabilities required to manage competing priorities in an international clinical research environment. Education: Bachelor's degree or equivalent in a scientific discipline. A qualification in Regulatory Affairs is an advantage. Professional experience: Three to five years of clinical regulatory affairs experience within the pharmaceutical, biotechnology, or contract research organization (CRO) industry. Submission expertise: Practical experience preparing and submitting Institutional Review Board (IRB) or Independent Ethics Committee (IEC) packages and/or Clinical Trial Applications (CTAs). Regulatory knowledge: Strong understanding of global regulatory requirements and guidelines applicable to assigned countries and regions. International regulatory leadership: Experience coordinating or leading regulatory activities across multiple countries, particularly in Europe and the Asia-Pacific region, including Australia and New Zealand. EU regulatory framework: Experience with the European Union Clinical Trials Regulation (EU-CTR) and its associated regulatory processes. Communication: Fluency in English, with excellent written and verbal communication skills. Additional languages are an asset. Attention to detail: A high level of accuracy and consistency when preparing, reviewing, and managing regulatory documentation. Organization and prioritization: Ability to manage multiple assignments, organize workloads independently, meet deadlines, and perform effectively under pressure. Adaptability: Comfortable working in a multitasking environment while balancing changing priorities and project requirements. Teamwork and leadership: Strong collaboration, mentoring, and knowledge-sharing skills, with the ability to support colleagues and maintain high-quality standards. Location and work authorization: The role is advertised for Brazil; however, the original vacancy specifies eligibility to work legally in Australia. The applicable location and work authorization requirements should be confirmed with the hiring team. Benefits Employment stability: Permanent, full-time position. Flexible working arrangements: Flexible work schedule to support work-life balance. Comprehensive benefits package: Medical, dental, and vision coverage. Retirement savings: Registered Retirement Savings Plan (RRSP) benefits, subject to applicable eligibility. Time off: Vacation entitlement and personal days. Healthcare access: Access to a virtual medical clinic. Commuting support: Public transportation rebates. Team culture: Social activities and opportunities to collaborate with experienced professionals in a supportive environment. Professional development: Ongoing learning, training, and career advancement opportunities. Meaningful work: The opportunity to contribute to international clinical research projects and support regulatory compliance across multiple markets.