JOB SUMMARY

• Responsible of planning and execution of regulatory strategies for the registration and lifecycle of products, including managing of queries , according to local regulations and, company's procedures and policies.

• Interact with key stakeholders, such as the LatAm Regional Hub, Labeling, PS, GCMC, PGS, Legal, Quality, etc. to ensure the regulatory strategy is executed in a timely manner.

• Work in collaboration across the Cluster and relevant functions for any requirement related to the portfolio assigned, and to deliver efficiencies in regulatory submissions,processes, and compliance.

• Possess a thorough and up-to-date understanding of the market regulatory requirementsand processes.

• Coordinate the activities related to drug product submissions for registration, variation, renewal, response to queries, others.

• Work closely with the Regional Hub to ensure regulatory submissions are ready to file in compliance with local regulations.

• Provide the necessary information to ensure internal systems and databases are updated to share accurate regulatory information with local and above country areas.

• Develop partnership with in-country teams (e.g. Quality, Medical, Marketing, Supply Chain), to facilitate the implementation/execution of regulatory strategies to expedite the registration of new products, line extensions, post approval changes and life-cycle optimization.

• 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.

• Collaborates with definition of labelling and artwork updates strategy with the regional responsible person for labeling and artwork, to manage the CMC, safety or legal entity changes with an impact on the labelling and artwork of each product.

• Support bidding processes by providing updated regulatory documents.

• Provide regulatory support to PBG and platform local areas (Supply, Quality, Safety, etc) to contribute to the achievement of business objectives.

• To help the supporting / business departments of the company in regulatory issues associated with the products under this position's charge, providing input to the marketing and commercial teams in relation to processes and regulatory strategies.

• Provide input to Regulatory Strategist Regional Hub of the regulatory strategy for the development and registration of products in line with business objectives, ensuring strategies that properly reflect each country's plans and aligning regulatory activities with business plans relevant to country or countries under his/her responsibility.

• Receive and review BoH (Board of Health) correspondence for products under his position's responsibility that must be managed based on internal SOP and procedures.

• Execute the activities required during an AQRT processes previously defined with the Regulatory Sciences Head.

• Interact with Health Authorities, external stakeholders or Trade Associations according to local needs and strategies defined with Regulatory Sciences Head of the cluster.

• 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.

• Education: Pharmacist degree

• Experience: About 4 years as a Regulatory Sciences Specialist, Coordinator or similar.

• In-depth knowledge of small molecules and biologics and local applicable regulation.

• Good understanding of drug products international regulations and standards, e.g.: WHO, EMA, FDA .

• New Molecules Commitee meetings experienced.

• English language advanced (oral and written).

• Customer-oriented

• Results-oriented

• Negotiation

• Planning and organization

• Strategic thinking

• Analysis and problem solvingEffective Communication

• Team player

• Agility and adaptability