Pfizer
Australia - New South Wales - Sydney
Is responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products for their assigned markets and updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements.
This role may act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence in collaboration with other Hub Labeling Managers.
Additionally, this role will serve as an SME for the use and development of current and new global tools, technologies and processes to support label development, submission and approval; with a particular focus on digital solutions.
• 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.
• Produces other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supporting documentation.
• Performs QC check of other colleagues’ work.
• Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
• Meets defined targets on productivity, quality and compliance, as set by and overseen by management.
• To support provision of other deliverables within the scope of IL 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
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.
• Strong knowledge/understanding of the principles and concepts of labeling.
• Strong knowledge of key regulatory and labeling principles and local regulations.
QUALIFICATIONS
• Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
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. (Preferred)
• Demonstrated project management, attention to detail and problem-solving skills.
• Proven strength in logical, analytical and writing ability essential (Preferred)
Work Location Assignment: Hybrid
*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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Regulatory Affairs