JOB RESPONSIBILITIES

• Possess a thorough 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 productregistration, 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.
• Work in partnership with the LatAm Regional Hub.
• Coordinate the preparation of the registration license renewal for all Innovative products.
• Participate in meetings with Agency, Trade Associations and other Agencies related to drug registration.
• Review and ensure processes related to exportation documents.
• Support bidding processes by providing updated regulatory documents.
• Contact the BoH by elaborating documents, e-mails, phone contacts and meetings for following-up processes of registration approval.
• 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.

QUALIFICATIONS / SKILLS

Qualifications:

• Education: Pharmacist degree
• Experience: About 4 years as a Senior Regulatory Sciences Analyst.

Technical Skill Requiremtents:

• 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

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