Roles and Responsibilities
Strategy and Development:
1. Support Group leader -ANZ in providing input and support for regulatory strategies in the development of product and dossier compilation to meet the timeline and in line with organizational objectives
2. Support Due diligence in the ANZ region and drive smooth execution of due diligence in collaboration with key stakeholders.
3. Thorough understanding of TGA and Medsafe guidelines and requirements
Submission & Approval Management:
1. Ensure the review and submission of dossiers in accordance with the health authority requirements TGA and Medsafe
2. Maintain files/databases/trackers to reflect up-to-date registration, change control, and post-approval changes and update the central database for new submissions in ANZ.
3. Maintain current registered/commercialized products: RA table preparation, Artwork/SPMS review, Product list updation for Technical agreement
4. Preparation for the package for clone application, TGA GMP Clearance, and review of variation packages
5. Managing third-party projects – Due diligence in ANZ region and drive smooth execution of due diligence in collaboration with key stakeholders.
1. Handling Authority/Customer/Consultant queries
2. Ensure partnering, collaboration, interactions, and coordination within International Regulatory, Regulatory operations (Dossier and Life cycle management team), API, and other functions including Formulation and Analytical Development, Business teams, Project Management, QA, and Mfg. units etc.
3. Building relationships with other stakeholders and liaising directly with the business and supporting ANZ group leader to organization goal.
Support group ANZ in providing timely update/escalation for top priority project
Learning and Development:
1. Attending training sessions conducted by GL’s/TL on regulatory requirements, working and handling internal software systems such as Cipdox, SAP, Documentum, Extedo, trackwise, etc. implementing the same for their day-to-day activity.
Desired Candidate Profile
Pharma Graduate with minimum 2 years experience in RA