AbbVie Regulatory Affairs Associate in Sydney, Australia
Regulatory Affairs Associate
Australia, New South Wales, Sydney
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries.
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Summary of Job Description:
To deliver successful regulatory submissions and approvals, to ensure that products within an assigned portfolio comply with local regulatory requirements (ANZ) and to support the commercialization of products through participation in local brand teams.
Management of all regulatory submissions within the relevant product portfolio in accordance with agreed business priorities
Planning and management of variation applications for assigned products
Maintaining regulatory records for assigned product portfolio in compliance with local and global procedures
Manage interactions with TGA and Medsafe and maintain a productive working relationship with these authorities to optimize regulatory outcomes
Develop and maintain an up-to-date working knowledge of the compounds, diseases and competitors relevant to the product portfolio
Develop and/or maintain a good working knowledge of relevant regulatory guidelines and procedures.
Participate in/coordinate support for any additional authorisations (eg. GMP, permits & licences) as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager
Develop and/or maintain cross-functional relationships with key global regulatory personnel and affiliate medical, commercial, operations and market access contacts
Support the commercialization of products through participation in local brand teams
Provide comment on TGA/Medsafe consultation documents as required
Minimum Skills Required:
A commercial focus and a desire to contribute to the overall success of the business
Ability to work autonomously as well as part of a cross function team
Well organised with an ability to meet deadlines and achieve goals
Good oral and written communication skills
Good attention to detail
Ability to critically appraise data
Ability to work in a high paced environment
Good proficiency for Microsoft Office (Word, Excel, PowerPoint)
Knowledge / Education Required:
Tertiary qualifications in pharmacy or life sciences
Experience in the pharmaceutical industry is desirable, but not essential
Quality, Safety & Environmental Responsibilities:
Attend regular departmental meetings with manager/supervisor to build in continuous feedback mechanisms.
Meet the requirements of ISO and any other departmental audits by complying with all relevant Regulatory and Quality policies and procedures to ensure the Regulatory and Quality objectives of the business are met.
Comply with all relevant company Occupational Health, Safety and Environmental policies, procedures and work practices with the intent of preventing or minimising accidental exposures to self, colleagues and/or the environment.
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