Technical and Regulatory Affairs Manager
Manage regulatory and technical aspects of new/modified pharmaceutical products (prescriptions, OTC) for a global pharmaceutical manufacturing comp.
Summary about this job
Pharmaceuticals & Medical Devices
Company: On Q Recruitment Pty Ltd
Location: Sydney
Work type: Full Time
Salary: n\a
Phone: +61-2-5527-7836
Fax: +61-2-7118-2249
E-mail: n\a
Site: n\a
Detail information about job Technical and Regulatory Affairs Manager. Terms and conditions vacancy
In this role you will initiate, manage and undertake activities as part of a Regulatory team with the responsibility for product registrations and maintenance of existing and new pharmaceutical products as well as provide strategic advice and direction to the global management team. This will involve leading a small team and the coordination of projects, as required.
You will act as a single point of contact with knowledge of the ANZ Chemical Manufacturing Controls (CMC) regulatory requirements while ensuring that TGA, Medsafe, GMP and pharmaceutical and manufacturing standards are met. Participate in and make contribution to new product launch projects and engage with both internal and external stakeholders.
This position will require: a degree in a scientific discipline, extensive experience in the pharmaceutical industry in regulatory and technical with a minimum of three in regulatory affairs. Experience in preparing submissions for OTC and Prescription medicines and variation changes for TGA is essential. This is an opportunity to demonstrate your strong project and time management skills. You will have strong collaboration and excellent communication skills.
This role is based in Sydney, and an attractive salary package will be on offer for the successful candidate.
Please send your Cover Letter and Resume in Word Doc Format (no text boxes or tables please) and follow the Apply Links. Visit onqrecruitment.com.au to review all our current vacancies.