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Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Summary:
We are seeking an experienced Regulatory Affairs Professional to join our Pharmaceutical Regulatory Consulting team in Australia. This role offers the opportunity to collaborate with a diverse range of clients, primarily in the pharmaceutical and healthcare sectors.
Your key objective will be to maximise client commercial success by ensuring regulatory compliance, licensing, and marketing authorisation for their products. You will provide expert guidance, manage regulatory submissions and approvals, and coordinate with clients, regulatory teams, and third-party subject matter experts.
This role requires proactive engagement and collaboration with global, regional, and local colleagues to drive regulatory excellence. As a Senior Associate, you will be part of a team of highly skilled Regulatory Consultants, working together to deliver the best outcomes for our clients and the patients they serve.
Responsibilities:
Manage regulatory submissions and lifecycle maintenance for Australia and New Zealand.
Ensure compliance with TGA & Medsafe regulations, industry standards, and company policies.
Develop strategic regulatory solutions to support product approvals and expansions.
Provide guidance on regulatory requirements for new and existing products.
Liaise with health authorities and manage regulatory interactions.
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Education:
Requirements:
A minimum of 5 years’ experience working in regulatory affairs within the pharmaceutical or healthcare industry or in a consulting setting.
Excellent project management and stakeholder engagement skills.
Ability to work independently and in a fast-paced consulting environment.
You thrive on diversity and challenge and can effectively project manage and deliver several projects at once.
What 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.
You thrive on diversity and challenge and can effectively project manage and deliver several projects at once.
Our head office is based in North 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.
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time
Affiliated Companies: PharmaLex Australia
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
