Specific Activities and Responsibilities:

Must have expertise in Health Authority communications for Initial filings, LCM Activities and for variation submissions.

 

Must have experience and thorough knowledge of the process of submissions at HA without missing any detail or deadline.

 

Must be competent with the current changes and regulations from the HA.

 

Will be able to provide local support for clients submission filings specially in AU/NZ.

Required education:

Masters in Pharmacy (preferable), Bachelors can be considered for rightful candidates

Required experience :

minimum 5 years in Regulatory Affairs

Required technical skills:

Basic computer skills including MS Word, MS Excel, MS Power point along with proficiency in client communication, understanding, acknowledging and reverting the mails on time.

Additional experience and/or skills:

Must be equipped with regulatory knowledge for APAC region in terms of Initial filing, LCM management, variation submissions with HA.

Regulatory Affairs Specialist (Australia, New Zealand)