Regulatory Affairs Senior Specialist

Add expected salary to your profile for insights Position Title: Regulatory Affairs Senior Specialist Reports To: Quality and Regulatory Lead Location(s): Australia Purpose of the Function The Regulatory Affairs Senior Specialist is responsible for maintaining a portfolio of products, preparing regulatory applications for submission, promoting regulatory compliance through active participation in the company’s change management process, and maintaining and supporting export product registrations worldwide. The role also supports the development of new products, provides regulatory advice on local and international agency obligations, and communicates with internal and external stakeholders. Additionally, the position fosters the professional and personal development of other staff within the Regulatory Affairs Department. Reporting Line Reports directly to the Quality and Regulatory Lead. Roles and Responsibilities Regulatory Affairs Compliance Activities Develop and execute global regulatory intelligence strategies, including comprehensive assessments of CMC dossiers and changes, ensuring alignment with evolving requirements. Critically evaluate supporting documentation to guide risk management and regulatory acceptability. Lead regulatory evaluations for new product development, investigations, and product/facility changes through Project Initiation, Sourcing, and Change Management processes. Oversee compilation and submission of regulatory dossiers (CTD, ACTD, regional), ensuring compliance with country-specific Ministry of Health guidelines and facilitating successful product registrations. Review and approve QA documents and regulatory submissions, including package insert labelling, to maintain the highest compliance standards. Build and maintain strategic partnerships with external stakeholders, promoting compliant change management and a culture of regulatory excellence. Drive regulatory strategy for LumaCina, including development, authorship, and review of CMC submission components. Support pre- and post-approval supplements, annual reports, renewals, and responses to health authority queries, embedding best practices and continuous improvement. Identify and mitigate regulatory risks, communicating enterprise-level impacts and implementing strategies to safeguard organizational interests. Ensure delivery of regulatory milestones across the product lifecycle, aligning and empowering cross-functional teams to achieve objectives. Advise LumaCina business leaders on emerging regulatory issues and opportunities for innovation. Manage deficiency responses to regulatory agencies, ensuring timely and effective resolution. Prepare and submit GMP clearances for API manufacturers and sub-manufacturers in accordance with Australian requirements. Develop and maintain regulatory policies and procedures to ensure ongoing compliance and operational excellence. Key Relationships Represent the Regulatory Affairs Department at meetings with partners, industry groups, and regulatory agencies. Foster effective relationships with internal and external stakeholders. Team Coordination Acts as a nominated delegate for the Quality and Regulatory Lead during absences, providing departmental representation and leadership as required. Providing leadership to the regulatory team. Organisational Support Suggest improvements for departmental operations and procedures. Respond promptly to reasonable requests from other departments. Contribute to overall company objectives. Statutory Obligations & Environmental Health and Safety Conduct oneself in line with relevant legislation regarding workplace health and safety, discrimination, harassment, and bullying. Participate in and take responsibility for workplace environment, health, and safety as required. Skills and Competencies Knowledge of global regulatory requirements and product registration processes (TGA, Medsafe NZ, FDA, EMA, MOH, ICH guidelines, GMP, etc.) Proficiency with Regulatory Information Management Systems (RIMS) and document management tools (e.g., eCTD) Project management and ability to meet deadlines Adaptability to changing regulations and priorities Strong attention to detail and organizational skills Analytical and problem-solving skills Ability to work collaboratively in cross-functional teams Familiarity with Good Manufacturing Practices (GMP) and quality systems Strong computer skills, including Microsoft Office Suite and regulatory database Education, Experience and Qualifications Education/Qualification Bachelor of Science (or equivalent) in Chemistry, Life Sciences, Pharmacy, or related field. Advanced degrees or certifications in regulatory affairs are advantageous Experience Proven track record in Pharmaceutical Regulatory Affairs (preferably human ethical products) with a minimum of 5–7 years’ experience and supervisory experience, or equivalent technical expertise and leadership skills. Successful registrations of ethical products and collaboration at national and international levels. Experience in preparing and filing Marketing Authorisation applications and variations, with sound knowledge of Chemistry, Manufacturing and Controls, and/or Regulatory Compliance principles. Your application will include the following questions: Which of the following statements best describes your right to work in Australia? How many years' experience do you have as a Regulatory Affairs Specialist? What's your expected annual base salary? How much notice are you required to give your current employer? #J-18808-Ljbffr