JOB SUMMARY

Is responsible for executing the content management of LPDs, LLDs and PLDs for nationally registered products for their assigned products across multiple countries/regions.

Acts as a subject matter expert for local labeling throughout the organisation, leading or assisting in the most complex labeling projects or initiatives, and contributing to the use and development of current and new tools, technologies and processes to support global label development, submission and approval.

Sharing of intelligence and contribution to knowledge resources is also a key part of the role.

The Senior Manager is proactive in gathering, assessing and disseminating regulatory intelligence for use by the labeling managers as well as for use in strategic decision-making at the global group level.

The Senior Manager will insightfully seek technology solutions leveraging process automation and Artificial Intelligence (AI).

May lead/manage projects. May supervise/lead colleagues/teams. May act as delegate/deputy for the TLs.

JOB RESPONSIBILITIES

• To utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate.
• To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing.
• To work on projects involving the use of current and new global tools, technology and processes to support label development, submission and approval; with a particular focus on digital solutions.
• To take part in research incubator work leveraging technologies in process automation, machine-learning, business process management etc.
• To work with R&D lead(s) with digital transformation project activities, to transform regulatory data, systems and processes into an integrated, hyper efficient learning platform, corresponding to GRS’s overarching roadmap.
• To assist with labeling data analysis.
• To create or enhance SharePoint web pages.
• The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as complex revisions
• For deliverables in scope, prepares responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions, and represents Pfizer during HA Inspections
• May mentor, train or supervise more junior labeling managers in their day-to-day activities, and may review work completed by other colleagues.
• May coordinate complex labeling activities when there is a regional, global or therapeutic area impact across multiple countries.
• May lead regional SME forums on labeling processes and clearly articulate expectations of the labeling process to a broad range of stakeholders.
• Interprets internal/external business challenges and best practices to recommend improvements to products, processes, or services.
• Takes appropriate risks to advance innovative processes and methodologies based on comprehensive business knowledge.
• May represent the function or region on project improvement initiatives.
• Leads operational team(s) within and across Work Teams and Departments, taking responsibility for the team's milestones/deliverables.
• Meets strategic targets for labeling deliverables as defined for the function, and communicates progress against these targets or issues which affect these targets, and proposes remediation.
• Contributes to definition of goals and group targets, and proactively feeds back issues and roadblocks to senior management.

SKILLS

• Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures.
• Fluency in English language important however multi-language skills are advantageous.
• Clear and effective written and verbal communications.
• Understanding of the importance of SOPs, systems and processes in underpinning quality and compliance of deliverables.
• Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access.
• Comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding/knowledge of principles and concepts of other labeling-related disciplines.
• Understands and applies labeling regulation in the region and in assigned local countries and is able to interpret impact of that regulation on development of labeling text. Is aware of forthcoming changes in regulation and legislation and the impact on labeling deliverables.

QUALIFICATIONS

• Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
• Advanced academic qualifications/degree such as PhD.

EXPERIENCE

• Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
• Demonstration of attention to detail and problem-solving skills.
• Proven technical aptitude and ability to quickly learn new software.
• Proven technical aptitude and ability to quickly learn regulations and standards.
• ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs; preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs.

• Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label

• Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important.
• Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
• Demonstrated project management, attention to detail and problem-solving skills.
• Proven strength in logical, analytical and writing ability essential

 
Work Location Assignment: Hybrid

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:

• Paid parental leave

• Access to Health & Wellness apps

• Career Growth Experiences program

• Recognition & rewards program

• Paid volunteer days

• Life Insurance Benefits

• Pfizer Learning Academy access to top content providers

• Access to flu vaccines & skin checks

• Options to purchase additional leave

• Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.

Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.

Regulatory Affairs