Senior Regulatory Affairs Specialist

Summary about this job

Detail information about job Senior Regulatory Affairs Specialist. Terms and conditions vacancy

• Great opportunity to join a highly competent and ambitious professional team on a permanent basis
• Competitive salary package on offer

About the organisation and the position

A leading European Pharmaceuticals, based in the lower North Shore of Sydney and operating in the four corners of the globe is seeking an experienced Regulatory Affairs Specialist to join the team. As a key member of the Medical & Regulatory Department, you will have a solid track record in the registration and maintenance of all regulatory activities to obtain necessary regulatory approvals, compliance and viability in the marketplace.

You will be directly reporting to the firm’s Head of Medical providing support through the co-ordination and implementation of Registration, Reimbursement and Clinical Trials. You will contribute proactively as an effective team member, functioning responsibly and autonomously while working within the framework of the TGA & Medsafe’s regulatory guidelines and procedures.

The right applicant will (preferably) possess a relevant degree in Life Science or Pharmacy. She/he will be highly articulate and willing to play a key role to service and liaise with the company’s Head of Medical. It will be essential to ensure that all activities are compliant with the internal and external regulatory guidelines and procedures.

Responsibilities

You will be responsible for the company’s registration and maintenance of all regulatory activities.

Responsibilities will include but may not be limited to:

• Prepare and submit Regulatory affairs applications to TGA and Medsafe to meet the firm’s business objectives and timelines
• Perform regulatory maintenance of all registered products to ensure compliance with all relevant authorities’ requirements
• Liaise with all relevant corporate functions (Regulatory Affairs, R&D and Reimbursement) to obtain supporting documents for projects completion
• Develop and manage effective working relationships with all relevant stakeholders (TGA, Medsafe, key Government & Federal bodies, company’s customers & other functional departments)
• Perform all Regulatory activities in a timely and accurate manner
• Liaising with other company’s departments by providing insights of Reg. Aff. matters
• Other duties as required by the manager

Skills and experience

• Tertiary qualified (Life Science or Pharmacy preferred)
• At least 4 to 5 years of experience in a similar role within devices (class III), pharma and OTC (if possible)
• Technical competency with TGA & Medsafe regulations, NCE experience (Category 1), minor variations
• Highly proficient user of Microsoft Office (Outlook, Excel, Powerpoint, Word) and Adobe Professional
• Excellent understanding of the Regulatory Affairs function
• Outstanding organisational skills
• Excellent oral, written, and presentation skills
• Excellent team player able to work independently, collaboratively and cross-functionally in a fast-paced environment
• Experience in exceeding customer needs whilst respecting deadlines
• Being proactive and taking initiatives
• High attention to details
• Strong ability to quickly adapt to any expected and/or unexpected change within the working environment
• Must be a citizen/PR of Australia/New Zealand

Please be aware that only shortlisted candidates will be contacted.

For more details, please contact Chris on [email protected] or 0410 436 870.