Senior Associate Hub Labeling Manager

This is a Senior Associate Hub Labeling Manager role with Pfizer based in Sydney, NSW, AU
== Pfizer ==

Role Seniority - mid level

More about the Senior Associate Hub Labeling Manager role at Pfizer

JOB RESPONSIBILITIES

• Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.

• Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs where there are unambiguous relationships to source documents and clear local regulatory principles to follow, requesting advice or input from other functions when 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.

SKILLS

• Basic knowledge/understanding of the principles and concepts of labeling.

• Knowledge of key regulatory and labeling principles and local regulations.

• 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.

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. (Preferred)

• 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. (Preferred)

• 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

Before we jump into the responsibilities of the role. No matter what you come in knowing, you'll be learning new things all the time and the Pfizer team will be there to support your growth.

Please consider applying even if you don't meet 100% of what's outlined

Key Responsibilities

• Contributing to project completion
• Producing labeling documentation
• Performing quality checks

Key Strengths

• Basic knowledge of labeling principles and concepts
• Knowledge of regulatory and labeling principles
• Clear and effective communication skills
• Experience with structured data
• Multi-language skills
• Attention to detail and problem-solving skills

Why Pfizer is partnering with Hatch on this role. Hatch exists to level the playing field for people as they discover a career that's right for them. So when you apply you have the chance to show more than just your resume.

A Final Note: This is a role with Pfizer not with Hatch.

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