Compliance Regulatory Artwork and Labeling Stategist

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.-
- 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.

JOB RESPONSIBILITIES-
- Develop detailed understanding of labeling and artwork regulatory guidelines and technical requirements for the country(ies).- Responsible for the execution of labeling and artwork processes in cooperation with in-country stakeholders.- Prepare and/or coordinate dossier preparation guaranteeing quality dossiers, fulfilling country regulations and Pfizer standards.- Guarantee timely regulatory authority submission of the dossiers according to labeling category and/or regulatory strategy.- Ensure submission and approval timelines, and country registration requirements/guidelines are accurately captured and current in Global Pfizer Systems.- Manage the process to answer regulatory authority queries in coordination with stakeholders to guarantee approval of updated labeling and/or artwork information reflecting global Pfizer position for products as best in class.- Coordinate with applicable teams the development and approval of the artworks.- Provide strategic support to the in-country regulatory strategists to facilitate achievement of labeling objectives.- Active participation and/or timely support in meetings, quality investigations and audit interviews impacting labeling and/or artwork operation.- Liaise and present information to all stakeholders using the most effective means of communication.- Contribute to the development of continuous improvement of business practices associated with processes and tools.

QUALIFICATIONS / SKILLS

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.

Work Location Assignment: Flexible

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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

LI-PFE