Menarini has an exclusive opportunity for a dynamic, self-motivated individual to join our Regulatory Affairs team as a Senior Regulatory Affairs Associate on a 12 month Maternity leave fixed term contract. The role is based in our Chatswood office in Sydney however location flexibility or remote work would be considered for the right candidate.
Menarini is a leading global biopharmaceutical company focused on delivering differentiated healthcare across consumer and ethical brands. We are headquartered in Florence, Italy and have a large presence in the Asia Pacific region.
The registration and maintenance of all regulatory activities in order to obtain necessary regulatory approvals, compliance and viability in the marketplace.
- Support new product registrations and major applications
- Compile, submit and project-manage Safety/Non-Safety PI and CMC updates for ethical and OTC products in Australia and New Zealand.
- Undertake ongoing maintenance of registered Menarini products and/or ingredients as required. Includes comprehensive gap analyses and dossier preparation.
- Maintain Product Information and Consumer Medicine Information ensuring the correct distribution and use of the approved versions of these documents.
- Review, update and submit the PSUR, RMP and ASA for registered products as required.
- Support and submit GMP clearance applications (MRA & CV)
- Develop and maintain good working relationships with Menarini cross-functional teams, regional office, health authorities and industry bodies.
- Assist Medical Information and Quality Assurance colleagues with product detail requests wherever feasible.
- Ensure all business activities comply with relevant Acts, legal demands and ethical standards in Australia and New Zealand.
- Provide adequate training and guidance and assist in the development of regulatory associates as requested by the Manager.
- Manage in-house regulatory files and documentation ensuring that all files are up-to-date and complaint.
Experience and Qualifications:
- Tertiary qualification in Pharmacy, Life Science or related field
- Minimum of 3 - 5 years’ experience in a Regulatory Affairs role in the pharmaceutical or biotechnology industry within the ethical vertical with proven experience in the following:
- planning, preparation and negotiation of submissions for chemical and/or biological entities (including Cat 1 type J submissions)
- all application types (including Category 1 and GMP applications – MRA and CV type) is highly desirable
- CMC variations (including Cat 3 and SAR)
- OTC, complementary, device and cosmetic areas highly desirable
- Sponsor transfer submission and due diligence experience
- Safety variations
- ASA reviews
- initiating and managing projects and actively engage in cross-functional meetings
- Understanding of relevant regulations and guidelines and ability to provide guidance to Menarini staff to ensure compliance with these.
- Planning and co-ordinating multiple complex projects simultaneously
- Strong computer literacy and command of Microsoft Office Suite, with ability to operate multiple information databases.
Skills and Attributes:
- Strong analytical skills and attention to detail ability to think creatively and devise pragmatic solutions to develop data into actionable information
- Ability to consolidate and logically present key findings to relevant parties.
- Ability to work well with cross-functional teams
- Strong interpersonal skills with demonstrated ability to drive consensus
- Exceptional persuasive written/verbal communication and presentation skills
- Willingness to present the facts and put forth hypotheses in the face of differing opinions
- Ability to adjust to changing needs within the organisation and flexibility to change priorities as need
- Intellectually curious to proactively research pertinent information to further inform/educate themselves in regulatory issues
- Demonstrated values-based skills and strong work ethic
- Ability to clearly understand highly technical scientific information.
Who we are:
At Menarini Australia our attitudes and behaviours are guided by our Vision, Core Values and Brand Promise. Collectively they make up our unique DNA and bind us to a common purpose and shared values. At Menarini we have an intrinsic belief that good health is essential to longevity and quality of life. We share a dream to empower healthier and happier living by playing a part to advance healthcare through our diverse therapeutic portfolio. As a family owned company we focus on long term performance through product quality and safety and we are sales and customer centric; fuelled globally by over 17,000 employees who treat each other with trust, fairness and respect.
We want the best to apply!
Menarini is a global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and foster an inclusive environment which benefits our people, patients and communities. We are interested in the best people working for us, which is why we adopt a responsible, open-minded approach to employment that complies with the Australian Fair Work Act.
If you believe that you have the energy, motivation and experience to join the organisation and that your contribution will significantly support our continued success then this could be an unrivalled, career opportunity.
How to apply:
If you would like to be part of this highly driven and successful team please submit your CV and a covering letter addressing the competencies above by Friday 1st October 2021.
You must have the right to live and work in this location to be considered for this job.
It is Menarini’s policy not to accept speculative resumes from Agencies, unless the role has been released directly to the agency. If we require your assistance on any roles, we will contact you at the time.