AbbVie Regulatory Affairs Manager in Sydney, Australia

Regulatory Affairs Manager

Australia, New South Wales, Sydney

Regulatory Affairs

Requisition #1805432

To deliver successful regulatory submissions and approvals, to ensure that products comply with regulatory requirements (ANZ) and to support the commercialisation of products through participation in local brand teams.Major Responsibilities:

• Lead and manage team by setting objectives, conducting performance reviews and development plans. Providing support, training and mentoring to RA staff

• With Director of Regulatory Affairs (DRA), agree local submission timelines for team projects

• Ensure ANZ submission requirements are communicated to relevant regional and global support teams for applications planned by team

• Ensure local regulatory submission strategies are developed for applications planned by team including extension of indications, as required

• Ensure team implementation of regulatory strategies in accordance with agreed business priorities

• Determine local regulatory risk for submissions planned by team and develop risk mitigation strategies where relevant

• Regulatory responsibility for an individual product portfolio (as required)

• Keep DRA informed of progress of applications and issues impacting team applications

• Ensure regulatory records for team projects and products are maintained 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

• Maintain excellent cross-functional relationships with key global regulatory personnel and affiliate medical, commercial, operations and market access contacts and to ensure cohesive stakeholder management and affiliate support.

• Develop and maintain an up-to-date working knowledge of the compounds, diseases and competitors relevant to the product portfolio

• Participate in/coordinate special project assignments as determined by the Director of Regulatory Affairs

• Participate in industry and TGA/Medsafe working groups and committees, where appropriate

• Support the commercialization of products through participation in local brand teams

• Work with DRA to ensure local regulatory processes and procedures are documented in SOPS and guidelines, reflect best practice and are compliant with global regulatory requirements

• Manage the RA budget.

Minimum Skills Required:

• A commercial focus and a desire to contribute to the overall success of the business

• A team player with an holistic approach to working in a matrix environment

• Well organised with a proven ability to meet deadlines and achieve goals.

• Leadership skills

• Good negotiation and influencing skills

• Good oral and written communication skills

• Ability to critically appraise data

• Well-developed technical regulatory skills

• Proven ability to provide innovative solutions to business challenges

• Good proficiency for Microsoft Office (Word, Excel, PowerPoint)

Knowledge / Education Required:

• Tertiary qualifications in pharmacy or life sciences

Experience Required:

• Extensive experience in registering new chemical entities and new indications within the ANZ environment

• Experience with Class I and II device inclusions desirable but not essential

• Cross functional brand team experience