Senior Manager, Hub Labeling

Pfizer, S.A. de C.V; Council of the City of Sydney; Hybrid; AUD 100,000 - 125,000; Full time

Job summary

A global pharmaceutical company is seeking a regulatory labeling expert to manage content for products submitted across various markets. You will execute labeling projects as a subject matter expert, focusing on innovative digital solutions and mentor junior staff. The ideal candidate will have a background in life sciences or pharmacy and display effective communication skills. This position is hybrid, offering a chance for engaging contributions and career development.

Benefits

Paid parental leave

Health & Wellness apps access

Career Growth Experiences program

Recognition & rewards program

Paid volunteer days

Life Insurance Benefits

Access to flu vaccines & skin checks

Options to purchase additional leave

Qualifications

• Strong working relationships across cultures.
• Attention to detail and readiness to solve problems.
• Ability to learn new software and regulations.
• Hands-on experience in Regulatory Affairs.
• Knowledge of global regulatory requirements.

Responsibilities

• Develop and deliver labeling documents for submissions.
• Support development of digital tools for labeling.
• Collaborate with R&D on regulatory transformation.
• Mentor junior labeling managers.
• Lead operational teams on project milestones.

Skills

Proficiency in business systems

Fluency in English

Clear communication

Understanding of SOPs

Experience with structured data

Knowledge of labeling regulations

Problem-solving skills

Education

Life sciences or pharmacy graduate

Advanced degree such as PhD

Tools

MS Excel

MS SharePoint

MS Access

Job description

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Job Summary

Responsible for executing the content management of LPDs, LLDs and PLDs for nationally registered products for 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. Shares intelligence and contributes to knowledge resources. Proactively gathers, assesses and disseminates regulatory intelligence for use by the labeling managers as well as for strategic decision‑making at the global group level. Seeks technology solutions leveraging process automation and Artificial Intelligence (AI). May lead/manage projects, supervise/lead colleagues/teams, and act as delegate/deputy for the TLs.

Job Responsibilities

• Utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate.
• Support provision of other deliverables within the scope of ILG responsibilities, e.g., readability testing.
• Work on projects involving current and new global tools, technology and processes to support label development, submission and approval, with a focus on digital solutions.
• Participate in research incubator work leveraging technologies in process automation, machine-learning, business process management, etc.
• Collaborate with R&D leads on digital transformation projects to transform regulatory data, systems and processes into an integrated, hyper‑efficient learning platform, aligned to GRS’s overarching roadmap.
• Assist with labeling data analysis.
• Create or enhance SharePoint web pages.
• Produce the full range of labeling documentation, including labels for NCEs or Product Extensions and complex revisions.
• Prepare responses to inquiries from Pfizer colleagues during inspection activities and regulatory agency questions, and represent Pfizer during HA Inspections.
• Mentor, train or supervise junior labeling managers and review their work.
• Coordinate complex labeling activities with regional, global or therapeutic area impact across multiple countries.
• Lead regional SME forums on labeling processes and clearly articulate expectations of the labeling process to stakeholders.
• Interpret internal and external business challenges and best practices to recommend improvements to products, processes or services.
• Take appropriate risks to advance innovative processes and methodologies based on comprehensive business knowledge.
• Represent the function or region on project improvement initiatives.
• Lead operational teams within and across work teams and departments, taking responsibility for their milestones and deliverables.
• Meet strategic targets for labeling deliverables and communicate progress and issues, proposing remediation.
• Contribute to definition of goals and group targets, proactively feeding back issues and roadblocks to senior management.

Skills

• Proficient in business‑expected systems and understands importance of systems in maintaining high compliance figures.
• Fluent in English; multi‑language skills are advantageous.
• Clear and effective written and verbal communication.
• Understanding of SOPs, systems and processes underpinning quality and compliance of deliverables.
• Experience working with structured data, enterprise databases, MS Excel, MS SharePoint and/or MS Access.
• Comprehensive knowledge of principles, concepts and theories of the discipline and good understanding of other labeling‑related disciplines.
• Applies labeling regulation in region and local countries, interprets impact of regulation on labeling text, and stays aware of forthcoming changes.

Qualifications

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

Experience

• Develop strong and positive working relationships across multiple cultures and locations.
• 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 in development, maintenance and commercialization activities within Regulatory Affairs, preferably from a country office or regional regulatory strategy perspective, with knowledge of Core Data Sheet implications on LPDs.
• Understand, assess and manage regulatory implications of product strategy with regard to the product label.
• Knowledge of global/regional regulatory guidelines and requirements, plus clinical variations.
• Interpret and apply regional/local regulatory guidance around labeling and supportive documentation, pre‑approval and post‑approval (maintenance) stages.
• Demonstrated project management, attention to detail and problem‑solving skills.
• Strong logical, analytical and writing abilities.

Work Location Assignment: Hybrid

Benefits

• 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