JOB SUMMARY
- Accountable for the labeling and artwork submissions execution ensuring country acceptability in terms of content, and alignment to local regulations and requirements. This includes regulatory authority query management.
- Apply knowledge and interpretation of regulatory requirements in the assigned country(ies) related to labeling and artwork processes.
- Ensure that the dossiers (example: electronic, paper copy, and regulatory authority portal) are built/submitted according to the regulatory strategy timelines.
- Ensure the processes transparency and excellence in execution of regulatory strategies.
- Work in collaboration across the organization with stakeholders (eg. Product Strategist, Commercial, Operations) to deliver efficiencies in regulatory submissions and processes.
- Work within a framework of internal SOPs, working practices and external regulatory requirements, so that the high-quality delivery of outputs and compliance is maintained.
Key Competencies
- Successful experiences of teamwork, seeking and proposing alternative solutions, achieving goals in an inclusive manner
- Project management skills
- Quality Focus and detailed oriented
- Customer orientation
- Analysis and problem solving
- Effective communication
- Strategically minded
- Outward looking
- Country/regional knowledge
- Negotiation skills
- Network and alliance building/ peer relationships
- Influencing
- Change agile
Qualifications
- Bachelor’s degree in Pharmacy.
- Previous experience in regulatory is an advantage.
- Knowledge of the current framework for labeling and artwork is an advantage.
- English language advanced level: reading, writing, speaking and listening skills that are easily manifested in known contexts regarding work. Fluency in Spanish and in Portuguese may be an advantage.
- Experience with Consumer Healthcare products
Work Location Assignment: Flexible
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
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