Will be responsible for taking full control of the department which includes providing support and development of staff as well as providing technical and regulatory oversight and guidance to the RA team and also to members from manufacturing area located at site.
The position is expected to spearhead, organize and lead contract with regulatory agencies or third parties
Position will ensure continuous and vigilant evaluation of regulatory strategy of products managed by group to identify any concerns and communicate the findings /potential solutions to the senior management, as required.
Expertise in Anticipation of regulatory consequences, Risk-benefit analysis, analytical thinking and critical evaluation of tasks will be necessary.
Overall responsibility for compiling regulatory submissions to the TGA, drafting Product Information, Consumer Information, literature searches to support submissions, TGAL product analysis, changes in manufacturing, pack sizes, CPI and PI development, packaging changes, MIMS notification and other regulatory activities.
Develop & build professional relationships with TGA staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
Working with marketing to ensure that the content of all promotional material is fully supported by the Product Information and literature, and in accordance with the guidance offered by the various Regulatory authorities.
Submissions of Dossiers in UK, Europe, Canada, Developed Nations and Rest of the world.
Sets quality and accuracy standards
Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests.
12 - 18 years experience in Regulatory Affairs is must.