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Lead Consultant in Regulatory Affairs
2 months ago
Your Role
We are seeking a seasoned Regulatory Affairs Professional to join our esteemed Pharmaceutical Regulatory Consulting team. In this position, you will engage with a diverse array of clients, primarily within the pharmaceutical and healthcare industries. Your main goal will be to enhance client commercial success by ensuring proper licensing, marketing, and regulatory adherence for their products.You will provide guidance, support, and oversight for regulatory submissions and approvals, collaborating closely with clients, regulatory bodies, and third-party experts. As a Team Lead, you will manage a group of highly skilled Regulatory Consultants dedicated to achieving optimal outcomes for our clients and the patients we serve.
Your Qualifications
You possess formal qualifications in a scientific discipline or a related field, along with a minimum of 10 years of experience in regulatory affairs, either in the pharmaceutical industry or in a consulting capacity. You are acknowledged as a technical authority within the Australian regulatory landscape, boasting a proven history of regulatory accomplishments throughout the entire product lifecycle. Extensive experience in prescription medicines Regulatory Affairs within Australia and New Zealand, particularly with new products such as Category 1 and New Medicine Applications, is essential. You have a strong background in leading regulatory evaluations for early-stage products and innovative technologies. You have held leadership positions, showcasing your ability to drive results through team collaboration and foster a positive team environment. You are a natural problem-solver and critical thinker, with a commercial mindset and exceptional communication and stakeholder management skills. You thrive in diverse and challenging environments, effectively managing multiple projects simultaneously.What We Provide
By joining the PharmaLex team, you will become part of a group recognized as specialists in our domain. Knowledge sharing and collaboration are integral to our daily operations. You will work alongside experienced Senior Managers, Associate Directors, and Directors with extensive consulting backgrounds. We are dedicated to fostering a culture where everyone feels valued and heard, creating an environment where we can all develop new skills and advance our careers. We offer a variety of flexible working arrangements, including adaptable start and finish times and hybrid work options. We embrace diversity and welcome experiences from various backgrounds. We invite you to submit your application, including a cover letter. Candidates must have full working rights in Australia.