Regulatory Affairs Associate, Dossiers

Blackmores Group is an Australian publicly-listed company, with an extensive presence across Asia Pacific. Our vision is to connect every person on earth to the healing power of nature by combining our knowledge of nature and science to deliver quality health solutions to people and their pets everywhere, every day. Recognising that you can’t have healthy people without a healthy planet, we’re strongly committed to embedding sustainability across our business and giving back to the communities in which we operate. 

As a purpose-led, performance-driven organisation, Blackmores Group strives to create remarkable employee experiences through supporting a diverse and inclusive culture, creating leadership that inspires high performance, and providing everyone with opportunities to achieve their professional, personal and wellbeing goals supported by our flexible work practices and family friendly policies.

Purpose of role:

The RA Associate will work closely with the RA Manager for dossier preparation for TH market, including registration, variation and renewal submission, and the focal contact point in the team for manufacturers related documents. 

Responsibilities include:

• Prepare dossier for TH FDA submission for food/drug products, including new registration , variation , renewal submission 
• Be focal point to contact oversee contact person in order for any request related to CPP, GMP and other document from manufacturer 
• Review the artwork for compliance 
• Reviewing product labelling and comply with FDA regulations

Who are you?

• 3 -4 years experiences in Regulatory Affairs field esp drug product 
• Degree qualified pharmaceutical science 
• Strong communication skills including written and spoken English 
• Understand regulations, guidelines and policies governing the healthcare industry (Pharmaceutical, Food, Cosmetic)
• Sound knowledge of manufacturing and quality controls related to ASEAN Harmonization Documentation
• Be able to evaluate relevant documents and determine appropriate action and able to provide the guidance and suggestion to other departments

Agencies please note: this recruitment assignment is being managed directly by Blackmores Talent Acquisition team. We will reach out to our preferred agency partners if required. Your respect for this process is appreciated.