Be an Early Applicant
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
The Hub Labeling Manager - Senior Associate is responsible for executing the content management of non-complex Local Product Documents (LPDs), Local Label Documents (LLDs) and Patient Leaflets (PLDs) for nationally registered products for their assigned products across multiple countries/regions.
Provides associated labeling support to the rest of the ILG organization, working in collaboration with Hub Labeling Managers.
Job Responsibilities
Skills
Qualifications
Experience
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs
Provides associated labeling support to the rest of the ILG organization, working in collaboration with Hub Labeling Managers.
Job Responsibilities
- Supports Hub Labeling Manager (Manager) by maintaining system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system. Maintenance of workflow management tools and mailboxes.
- Provides ad hoc support for labeling deliverables.
- Performs QC of labeling text.
- Monitors system data integrity and quality checks.
- To maintain system management for labeling activities including GDMS and Pfizer approved labeling tracking system.
- 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.
- Basic 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.
- Knowledge of key regulatory and labeling principles and local regulations.
Qualifications
- Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience. - Required
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. - Required
- Proven technical aptitude and ability to quickly learn new software. - Required
- Proven technical aptitude and ability to quickly learn regulations and standards. - Required
- '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. - Required
- Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label. - Required
- Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important. - Required
- 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
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs
What the Team is Saying
Daniel
Diagnostics Launch Lead
Anna
R&D Privacy Steward
Esteban
Specialist
Similar Jobs
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
Gallery
Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
Not Specified
Hudson Yards
Provincia de Buenos Aires
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Andover, MA
Athens, GR
Chennai, IN
Collegeville, PA
Cork, IE
Dublin, IE
Durham, NC
Groton, CT
Kildare, IE
Madison, NJ
Madrid, ES
Mumbai, Maharashtra
Rochester, MI
San Diego, CA
Seattle, WA
Heights Union East
Center for Digital Innovation
Learn more
