Manager Regulatory Affairs
1 week ago
Job Description:
At Ferring Pharmaceuticals, we help people around the world build families and live better lives.
We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women's health, gastroenterology and urology.
Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.
Our Commercial teams collaborate as trusted partners with patient groups, clinicians, policy makers and the scientific community to identify and develop new opportunities to help patients.
Customer centric, we offer an empowering, entrepreneurial culture – and a place to thrive and grow.Ferring+You
You will be responsible for managing the regulatory activities, prepare, and submit allocated regulatory submissions, responses and notifications to TGA, to ensure timely outcomes in line with the company's needs and in compliance with relevant Australian legislation and the conditions of registration.
Your day at FerringManage and prepare responses and mandatory reports for TGA (e.g Annual batch report, PSURs etc).
Manage and develop Product Information, Consumer Medicine Information, labels, Certified Product Details (or equivalent} and other documentation as required.
Assist in preparing and submit pricing applications.
Liaise with international Ferring regulatory colleagues as required (e g.
preparing Packaging artwork, obtaining dossiers/data for submission).
Prepare labelling and packaging mock-ups for regulatory submission using internal artwork management system (managing creation and approval)
Ensure all new and existing products are maintained on the ARTG.
Liaise, prepare and submit Certificate of Pharmaceutical Product for countries requesting these documents
Maintain the Global Regulatory Affairs Database (VEEVA).
Oversee, prepare and submit allocated device regulatory submissions, responses and notifications to TGA under the supervision of SAM.
Maintain the device registrations and up to date technical files.
Keep up-to-date with government legislation as it relates to regulatory affairs.
Behind our innovation...There's you
Minimum of 3-5 years of local experience in a similar Regulatory Affairs role with prescription medicines/medical devices.
Highly energetic and target-oriented, and possess excellent oral and written communication skills with meticulous attention to detail
You will thrive in a fast-paced environment and effectively deliver to tight deadlines.
Knowledge of/experience within the Reproductive Medicine, Gastroenterology and Urology/Uro-Oncology areas would be a distinct advantage.
Exceptional computer literacy and experience with MS databases/programs
Fluent in English (if not first language)
Demonstrated analytical skills
Graduate in a medical or related discipline: e.g.
physiology, pharmacy, biochemistry, or pharmacology.
Eligibility to reside and work in Australia
People come first at Ferring
Accredited Great Place to Work employer, offering hybrid and flexible work arrangements and comprehensive benefits for its employees
Get inspired from our commitment to advocate for everyone's right to build a family, no matter who you are, where you live or who you love
Our inclusive support package – "Building Families at Ferring" provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role
Parental leave for both birthing and non-birthing parents
Extended support on family building journey
Making a difference in the life of millions of people means we succeed by working together.
Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member's contributions.
Imagine the power of your career when it's Ferring + You.Behind our purpose... There's you
If our mission and your vision are aligned, please apply
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.
Location:
Ferring Australia
Supporting our employees' family building journeys At Ferring, we're committed to advocating everyone's right to build a family.
That's why we're launching our most inclusive and comprehensive family building benefits package yet.
The package recognises the complexities of building a family and aims to remove financial barriers associated with fertility treatment and family building options, by providing financial support and a global minimum standard of 26-weeks of paid parental leave.
We'll offer support for fertility treatments, surrogacy programmes, adoption, egg freezing, counselling and related services, as well as paid leave for fertility treatment and adoption procedures.
Ferring Project Family At Ferring, we believe in everyone's right to a family and we commit to building families of every shape and size.
Millions of people around the world are unable to access the care, treatment and support they need to build a family.
We want to change that.We are addressing some of the greatest challenges in reproductive medicine and maternal health through our research and development programmes.
Learn more about our #Family Project CommitmentDriven by its entrepreneurial spirit and enabled by a decentralised organisational setup, Ferring will harness its world-class competencies in science and business with other innovative technologies to create solutions for patients and doctors.
By developing an understanding of people's needs, we will deliver personalised healthcare solutions, integrating pharmaceutical products with diagnostics, data, devices, education and support services to optimise health outcomes.
Ferring will be the world-leading, most trusted healthcare company in reproductive medicine and maternal health, and a leader in specialty areas within gastroenterology and urology.
Each of us at Ferring will contribute to providing innovative solutions to help people live better lives.We will devote significant research and development investment to new therapeutics, life cycle management and next generation healthcare solutions.
As a privately owned, specialty healthcare company that operates globally, Ferring will grow revenues at a rate that is 50% faster than the industry average.
We will strive for efficiencies in our business and create flexibility to invest in opportunities to build our future.We are, and continue to be, part of a transparent and aligned company.
We strive to best address the needs of patients, stakeholders and customers by collaborating across functions, experimenting and sharing our practices, and continuously learning.
We are always guided by the Ferring Philosophy.You can take the first stepDon't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit#J-18808-Ljbffr
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