Associate Director, Regulatory Affairs
vor 3 Monaten
We are growing, grow with us
Are you looking for a dynamic company with daily new challenges and opportunities? Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective product maintenance.
Associate Director, Team Lead, Regulatory Affairs
Location - Sydney, Australia (hybrid)
Your Job
We have an opportunity for an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. In this role, you will work with a broad range of clients, predominantly in the pharmaceutical and health care sectors. Your primary objective is to maximize client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of client's products. You will advise, support, and manage regulatory submissions and approvals for products, including liaising with clients, regulatory teams, and third-party subject matter experts. As a Team Lead, you will have a team of highly skilled Regulatory Consultants reporting to you, and together you will be committed to achieving the best outcomes for our clients and the patients we serve.
Your Profile
You have formal qualifications in science or a similar field and a minimum of 10 years' experience working in regulatory affairs for prescription products in industry or a consulting setting.
You are recognized as a technical expert within the Australian regulatory environment, with a strong track record of regulatory work spanning the entire product lifecycle. Extensive experience in prescription medicines Regulatory Affairs within Australia and New Zealand, including new products such as Category 1 and New Medicine Applications, is required. You have extensive experience leading regulatory assessments for early pipeline products and new technologies.
You have worked in leadership roles, demonstrating the ability to achieve results through people and develop a positive team culture.
You are a natural problem-solver, critical thinker, commercially minded, and have exceptional communication and stakeholder management skills.
You thrive on diversity and challenge and can effectively project manage and deliver several projects at once.
We offer
By joining the PharmaLex Australia team, you will become part of a team renowned as specialists in our field. Sharing knowledge and expertise with others is part of every day. You will work closely with experienced Senior Managers, Associate Directors, and Directors who have extensive consulting experience.
We are committed to creating a culture where we all feel valued and heard, and a place where we can build new skills and capabilities and grow our careers.
Our head office is based in St Leonard's, Sydney, NSW, Australia. Ideally, candidates will be Sydney-based; however, Melbourne, Canberra, or Brisbane locations may be considered.
We offer a range of flexible working options such as varying start and finish times and hybrid working. We are a diverse workplace and welcome experiences from other countries and settings.
Please submit your application, including a cover letter. Applicants must be based in Australia and have full working rights.
If you are interested in joining our Pharmalex team for this challenging job opportunity in our future-oriented company, we look forward to receiving your application documents stating your earliest possible starting date, any visa requirements, and salary expectations online.
For further information, please don't hesitate to contact us:
Ms / Mr BrandenburgSenior Manager, Human Resources Australia
Agencies only by prior agreement for the specific job opportunity.
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