Regulatory Affairs Associates

Direct message the job poster from Scendea Are you looking to start or advance your career in regulatory affairs? At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our biotech and pharmaceutical clients. If you would like to begin or advance your career in regulatory affairs, and passionate about providing strategic and technical solutions to complex product development challenges, we'd love to hear from you. What's involved? You will play a critical role in providing regulatory guidance and innovative strategies across a wide range of medicinal product development activities. This exciting opportunity is ideal for someone wanting to start or develop a career in regulatory project management, regulatory affairs and medical / scientific writing. Successful candidates will have a strong interest in facilitating the entry of Client's compounds into clinical trials and assisting in the activities required for successful international marketing approvals. At Scendea, we provide the training and guidance to enable you to project manage the delivery of high-quality technical regulatory advice and product development strategies. You will be part of a highly professional, internationally recognised team, with opportunities for career progression within our rapidly growing Regulatory Consultancy. Key responsibilities Project management to ensure delivery of contracted activities, which will include direct contact with multiple clients and stakeholders. Complete relevant tasks within scope or under supervision to ensure successful project delivery with adherence to timelines and budgets. Support in the creation and delivery of high-quality billable related product development and regulatory-related documentation for clients. Develop and maintain technical knowledge in the area of product development and international regulatory affairs. Perform literature and data searches, collating and summarising data in an appropriate manner for stakeholders. Manage project documentation within company systems. Support and develop strategic drug development strategies in the area of regulatory affairs, Non-Clinical, Clinical, and CMC development. Assess and analyse scientific data. Qualifications A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree (e.g., a life science focused MSc or PhD). A general awareness of drug development and medical / regulatory affairs is required, and prior industry experience would be advantageous. Any experience with regards to medical / scientific writing would be a strong asset for this position. Excellent writing skills in English – you will be expected to summarise complex scientific data, thus facilitating the review of such data by external parties. High level of verbal communication and presentation skills in English, computer literacy, and competency in MS Office programs. Exemplary organisational and time management skills with a high level of attention to detail, ability to balance competing priorities, and to complete work within a set timeframe. Proven ability to work proactively, autonomously, and as part of a team. Some experience in project management would be a significant advantage for this role. This could include managing a research project (e.g., during a PhD). Willingness to work flexible hours and travel for short periods, sometimes at short notice, within Australia, and or internationally. A clear ambition to progress your career in medical / scientific writing and regulatory consulting. Commercial experience is not a prerequisite for this position. Why Scendea? Scendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer service. With a current team of over 50 staff based in the Australia, UK, Netherlands, and the US, Scendea is undergoing a period of significant growth, with the addition of new office locations and service lines to facilitate the delivery of expert and strategic global regulatory consulting services to our rapidly growing client base. We are equally committed to making a positive impact on society by managing our environmental impacts and contributing to a low-carbon economy. Our inclusive work culture values transparency, ethical collaboration with clients, and employee involvement in key decision-making processes, ensuring that our team is respected, supported, and engaged. Employee benefits Generous bonus program, which rewards success. Holiday plus public holidays, and discretionary additional days for birthday and work anniversary. Employer pension contribution. Access to Employee Assistance Programme. Employee Ownership Trust Scheme. A challenging and stimulating position for a dynamic and competent scientist, looking to contribute to a growing business and a rapidly expanding team. Coaching, mentoring and support of your continuous learning, and professional development within a highly recognised international team. Register your interest today We are always looking for talented individuals to join our global team. If this sounds like the next step in your career, click "Apply" to register your interest. #J-18808-Ljbffr