Regulatory Affairs Associate Manager
Regulatory Affairs Associate Manager
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Job Description
Purpose
Describe the primary goals objectives or functions or outputs of this position.
To deliver successful regulatory submissions and approvals to ensure that products within an assigned portfolio comply with local regulatory requirement and to support the commercialisation of products through participation in local brand teams.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Planning and management of major submissions to register NCEs or new indications to existing products within an assigned product portfolio.
Planning and management of variation applications for assigned products.
Perform and manage daytoday product registration operations and ensure timely completion of the registration tasks assigned in compliance with regulations guidelines and internal processes. - Maintaining regulatory records for assigned product portfolio in compliance with local and global procedures.
Manage interactions with TGA and Medsafe and maintain productive working relationships with these authorities to optimize regulatory outcomes. - Develop and maintain an uptodate working knowledge of the compounds diseases and competitors relevant to the product portfolio.
Maintain good working knowledge of relevant regulatory guidelines and procedures. - Participate in/coordinate special project assignments as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager.
Maintain excellent crossfunctional relationships with key global regulatory personnel and affiliate medical commercial operations and market access contacts to ensure cohesive stakeholder management and affiliate support. - Support the commercialisation of products through participation in local brand teams.
Provide comment on TGA/Medsafe consultation documents as required. - 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 Quality and Regulatory 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
Qualifications :
- Minimum 35 years regulatory affairs experience within the ANZ environment which includes the preparation and negotiation of major submissions for new chemical/biological entities and/or registration of new indications.
Experience with Class I and II device inclusions desirable but not essential. - Skills:
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 functional team - Well organized with an ability to meet deadlines and achieve goals
Good negotiation skills
- Good oral and written communication skills
Good attention to detail - Ability to critically appraise data
Welldeveloped technical regulatory skills - Proven ability to provide innovative solutions to business challenges
Ability to work in a high paced environment - Good proficiency for Microsoft Office (Word Excel PowerPoint)
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
