- Responsible for creation and maintenance of all regulatory documentation, including but not limited to, product packaging, labelling, inserts, working in conjunction with the marketing team for design, and assuring regulatory compliance across all territories.
- Monitor and nterpret international regulatory rule, guidelines and changes and ensure that they are communicated across the company
- Communicate with regulatory bodies and global team
- Prepare the Production department and local partners for with clear explanation of product export/import requirements, controlled drug regulations etc
- Complete regulatory submissions for domestic or international projects
- Support export and import permitting and licensing
- Advise teams on subjects such as premarket regulatory requirements, export, and labelling requirements, or clinical study compliance issues
- Review labelling, batch records, specification sheets, and test method
- Responsible for developing and maintaining global documentation for regulatory systems, including user manuals and training materials
- Participate in internal and external audits.
- Support new product development and further clinical activities.
- Create and maintain relevant regulatory documentation systems.
- Review clinical protocols to ensure the collection of data needed for regulatory submissions.
- Minimum tertiary qualification in relevent field
- 2+ years' experience engaging and global Health Authorities (preferrably EMA, MHRA, BfArM and/or HPRA)
- 5+ years' experience in pharmaceutical industry preferably prescription medicines, narcotics, experimental drugs or products supplied via access schemes
- Experience with prescription drug registration submissions and lifecycle management, including clinical trial activities
- Experience in project management
- Ability to negotiate with internal and external functions including Health Authorities
- Excellent written and verbal technical communication skills
- Up to date knowledge and experience of regulated domestic and international environments for therapeutic goods
- Solid understanding of risk management processes
ABOUT i-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
If you would like to discuss this vacancy further, please call Recruitment Consultant, Rachel Jennings on +61 (0) 2 8310 5846, or email firstname.lastname@example.org. If this role is not suitable, Rachel is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
Senior Quality Assurance Associate, Quality Manager, Quality Director, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Regulatory Associate, Senior Regulatory Associate, Regulatory Manager, Submissions/Documentation, QMS, CAPA, ISO 13485.