Regulatory Affairs Compliance Project Manager - Australia
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Regulatory Affairs Compliance Project Manager
AUSTRALIA & ASIA Region
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
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.