Regulatory Affairs Manager

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Job Details
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.

We are looking for Regulatory Affairs Senior Managers to come join us in Australia

Summary
We have an opportunity for an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. In this role you will have the opportunity to work with a broad range of clients, predominantly in the pharmaceutical and health care sectors.

Your primary objective is to maximise client commercial success by ensuring appropriate licensing, marketing and regulatory compliance of client's products. In this role, you will advise, support and manage regulatory submissions and approvals for products, including liaising with clients and regulatory teams and third-party subject matter experts.

In this role you will liaise proactively and work collaboratively with global, regional and local colleagues. As a Team Lead you will have a team of highly skilled Regulatory Consultants that will report into you and together you will be committed to getting the best outcomes for our clients and ultimately the patients we serve.

Education

• You have formal qualifications in science or similar field.

Skills

• Minimum of 10 years' experience working in regulatory affairs either for prescription products in industry or a consulting setting.
• You are recognised 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 and experience in new products, i.e., 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 leaderships 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 skills and stakeholder management skills.
• 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.
• We are committed to create a culture where we all feel valued and heard, and a place where we can all 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.

**What Cencora offers****
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****
Affiliated Companies: PharmaLex Australia

*Equal Employment Opportunity*
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 or email We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned