Regulatory Analyst

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 local 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 ALIM 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.

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