Manager Regulatory Affairs

2 weeks ago

Pymble, New South Wales, Australia Ferring Pharmaceuticals Full time

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 Ferring

Manage 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 documentsMaintain 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 detailYou 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/programsFluent in English (if not first language)Demonstrated analytical skillsGraduate 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 employeesGet 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 loveOur 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 roleParental leave for both birthing and non-birthing parentsExtended 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

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