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- Coordinate activities related to dossier submission (paper and/or electronic) for Innovative drug products for country acceptability in terms of content, according to local regulations and requirements. This includes HA query management.
- Interact with key stakeholders, such as the LatAm Regional Hub to ensure the regulatory strategy has been executed in a timely manner.
- Familiarize themselves with the latest changes in BoH legislation, and communicate this to the LatAm Regional Hub, to ensure the necessary systems and databases are updated as necessary.
- Work in collaboration across the region to deliver efficiencies in regulatory submissions and processes.
- Accountable for the Labeling and Non-Labeling submissions execution ensuring country acceptability in terms of content and alignment to local regulations and requirements. This includes BoH query management.
- Ensures the processes transparency and excellence in execution of regulatory strategies.
- Work in collaboration across the organization with stakeholders (such as Product Strategist, Commercial, Operations) to deliver efficiencies in Regulatory submissions and processes.
- Participation with Manager or Sr. Manager to provide suggestions or comments in the documents worked by Trade Association.
- Possess a through understanding of the market requirements, as well as the regulatory processes.
- Coordinate the activities related to submissions of Innovative drug products.
- Work closely with the LatAm Regional Hub to ensure submissions are ready to file, and provide the necessary information to ensure internal systems and databases are updated.
- Coordinate the routine monitoring of Agency's website for information related to product registration, line extensions and post-approval changes. Understand local regulations and trends.
- Ensure the team keeps current with the BoH legislation, as well as updates the regulatory information on Pfizer's intranet.
- Coordinate the review of submission ready dossiers, ensuring that submissions fully meet the local regulatory requirements. This includes BoH query response.
- Coordinate the preparation of the registration license renewal for all registered products.
- Support tender processes by providing updated regulatory documents.
- Complete departmental training in a timely manner to address corporate and regulatory needs.
- As applicable, contribute to local regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
- Develop detailed understanding of regulatory guidelines and technical requirements in the LatAm countries.
- Education: Pharmacist degree
- Experience: About 4 years as a Senior Regulatory Sciences Analyst.
- Relevant pharmaceutical experience
- Knowledge of local BoH requirements, as well as the requirements for the markets in the Cluster.
- Technical and scientific knowledge of pharmaceutical products.
- Proficiency in the English language is preferred.
- Customer-oriented
- Results-oriented
- Negotiation
- Planning
- Organized
- Decision making
- Communication
- Team player
- Change agile
Coordinador de Asuntos Regulatorios - Ciudad de México - Pfizer
Descripción
Regulatory Sciences Coordinator
Temporary role for 12months
Location: CDMX, Mexico
JOB SUMMARY
JOB RESPONSIBILITIES
Qualifications:
Technical Skill Requiremtents:
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.
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