BD (Becton, Dickinson and Company) Senior Regulatory Affairs Business Partner in Sydney, Australia
Job Description Summary
Co-ordinate the regulatory activities for assigned portfolio in order to meet the regulatory requirements for product registration and importation and assist the businesses in meeting company marketing plans.
- Manage regulatory activities involving compliance to government regulations and maintenance of product registrations and permits with the Therapeutic Goods Administration (TGA), the Australian Quarantine and inspection Services (AQIS) and other government agencies as required. Maintain similar activities with Medsafe and MAF in New Zealand;
1.1. Management of the preparation of regulatory submissions for general marketing applications to TGA and Medsafe;
1.2. Maintenance of manufacturer’s evidence with regulatory authorities
1.3. Applications for appropriate AQIS and MAF Import permits;
1.4. Manage any product notifications or recalls including the related activities, including all negotiation with the regulatory bodies and business units;
1.5. Respond efficiently to all Product Design Notifications (PDNs) issued by manufacturers;
1.6. Maintain regulatory records in the departmental database, Boulevard, when any changes are made to registrations.
Provide guidance and interpretation of regulatory requirements to project teams, Business Leaders and other appropriate ANZ Associates.
Review all New Material Request forms for assigned portfolio and advise businesses of requirements.
Assist the Director, ANZ, Regulatory Affairs with the review of promotional material to ensure compliance with BD and Industry Codes of Conduct.
Interface with Australian, New Zealand and worldwide BD Associates and regulatory agencies to resolve regulatory matters and expedite regulatory activities (i.e. new product launches, product design changes etc).
Ensure all activities are in line with departmental policies and procedures.
Provide back-up support to Team when and as needed.
Undertake project work as assigned by the Director, ANZ, Regulatory Affairs.
Adhere to the requirements of the Quality Management System as maintained by BD Australia.
(Skills, Knowledge & Experience)
Tertiary qualification in relevant field such as Pharmacy or Science.
Experience in regulatory activities.
Knowledge of TGA and AQIS regulations and Medical Device regulations, including IVDs would be an advantage.
Primary Work Location
AUS Sydney - North Ryde
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.