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Regulatory Affairs Compliance Project Manager - Australia  

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Posted on : 01 May 2017

Project Description

 

 

Job Description

Regulatory Affairs Compliance Project Manager

AUSTRALIA & ASIA Region

 

Part-time/Full time

Fixed term contract for 12 months

 

Purpose of the Position

 

To support the Regulatory Affairs function in meeting compliance objectives for Alexion registrations/licences in the Australia-Asia Region.

 

 

Key Tasks and Responsibilities

 

  • Manage Clinical Trial Notifications, TGA GMP clearances and AQIS permits
  • Project manage artwork updates for Asia;

     

    • Maintain regional regulatory information such as tracking post-authorisation commitments and archiving of Product Information, approved RMPs & RMP materials.
    • Creation of Regional RA SOPs as required, particularly around RMP and label processes.
    • Project Management of various label and RMP updates required

 

Qualification and experience needed for the position

 

  • 5+ years industry experience in the pharmaceutical industry, prescription medicine Regulatory Affairs function, particularly with a good understanding of regulatory compliance (SOP development) and management of RMPs and RMP materials. Experience with Asia-Pacific an added advantage.
  • Attention to detail
  • Strong project management skills
  • Ability to develop and execute action plans in an independent environment
  • Teamwork and communication skills
  • Organisational skills
  • Adaptability to a multicultural environment essential
  • Innovative and solution orientated

 

 

 

Sydney, Australia
 

 

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.