Position Title Head, Regulatory Affairs ANZ

Job ID	93431BR
Division	Animal Health
Business Unit	Animal Health
Country	Australia
Work Location	Sydney
Company/Legal Entity	AU Animal Health
Functional Area	Development & Medical
Job Type	Full Time
Employment Type	Regular
Job Description	As regulatory leader for the ANZ CBU, this role is responsible for managing the efficient regulatory registration of new products & ensures regulatory compliance of approved products as well as developing and implementing regulatory affairs related strategies. - Responsible for Agency relations by maintaining close contacts to the relevant authorities. - Responsible for thorough understanding of local requirements and has general understanding and knowledge of regulatory requirements for all countries supported. Competent authority interactions may range from written communications to in-person meetings within the scope of responsibility. Understanding of regulatory agency interactions and influences and how to leverage them to benefit the business. - Responsible for ensuring professional planning, competent RA input, efficient registration and maintenance of the registrations of existing marketing authorizations in accordance with business needs directions and strategies. Plan, direct and coordinate all regulatory activities of the assigned products or areas of responsibility in collaboration with country regulatory professionals, local CBU and project teams, ensuring successful implementation, follow through and completion of tasks. - Prepare, write and review documents (e.g. detailed and critical summaries, tabulated summaries) for products in development to be newly submitted globally or locally and for any post-approval submission, according to the latest regulatory requirements of the focus countries. - Lead and co-ordinate the technical documentation process and ensure that the required documents are generated to the appropriate quality by advising technical managers authoring them. - Ensure regulatory compliance by creating awareness of requirements and guidelines, facilitating timely submissions and strict participation in the global/local change control operations. Ensure regulatory compliance by timely submission of variations. - Apply procedures and systems necessary to maintain proper records and support adequate controls in line with GMP, external and internal quality requirements. - Advise business and provide strategic and tactical guidance/direction on regulatory matters, making recommendations and giving direction considering current and future trends and alternative business options. - Participate and represent RA and NAH in various teams, trade associations and professional organizations. - Provide leadership, direction & support to the regulatory affairs and pharmacovigilance team, developing local talent to sustain local & global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession and individual development plans. - Ensure that a local PV system is implemented to meet local and global regulatory needs. When required assist in assessing causality in animal sAE(s) and in determining case seriousness & timeline for submission. - Perform other related duties and assignments as required by the business and directed by management. - Comply with all company local and global policies including Quality, SOX, NFCM, Code of Conduct, Corporate Citizenship, NEM, EEO, anti-discrimination, harassment, and health, safety and environment (OH&S) policies.
Minimum requirements	• Bachelor's Degree or equivalent in life sciences, such as veterinary medicine, toxicology, pharmacy, chemistry. • Masters / PhD Preferred • Demonstrated regulatory affairs experience, preferably within animal health & the APVMA / AVCM • Leadership experience with direct reports and matrix / multi-disciplined teams, demonstrated communication skills both written and verbal • Demonstrated knowledge & awareness of current industry issues & evolving trends in the regulated environment; both domestically & internationally • Demonstrated leadership skills, including people management, building & developing talent • Fiscal responsibility & effectiveness • Skilled in risk / benefit assessment and approaches                                         Apply