Must be able to work from assigned Pfizer office 3 days per week, or as needed by the business. Manage assigned projects at a cluster level; Oversee strategy related to obtaining, managing and maintaining product Marketing Authorisations and support Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs.

Conduct associated strategic regulatory activities for assigned products and markets and contribute to the implementation and leadership of projects and building expertise within the cluster regulatory team.JOB RESPONSIBILITIES ## Cluster & Project Management* Responsible for identifying, implementing and managing key regulatory cluster/country projects either on an individual basis or as part of the Cluster leadership Team, to meet cluster regulatory objectives, including agreeing priorities with Head of Regulatory Sciences for the cluster/country as appropriate.
* Monitor regulatory activities across product therapy areas and assist with the management of projects as necessary to ensure compliance with regulatory authority and corporate requirements and timelines.
* People and Resource Management* Manage performance of direct reports to achieve agreed objectives, with high quality outputs, and to identify and address training and development needs.
* Ensure direct reports are supported and that direct reports have a manageable workload through redistribution, prioritisation or outsourcing of work, as necessary including planning of appropriate timelines and resource allocation.

Include consideration of individual strengths when allocated project/product responsibilities.
* Ensures that all regulatory activities in the team are managed in compliance with Pfizer standards and international/local regulations.



Deliver Regulatory Strategy and Advise Cross-Functional Teams* In line with assigned product and country responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.
* Represent Regulatory on cross-functional product teams and provide strategic regulatory input to the commercial operating planning process.
* Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate, including
* ensuring teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.
* Work with above country regulatory strategists to provide country specific input into Global and Regional regulatory strategies as required.
* Ensure alignment of local and regional regulatory strategy and tactics. Advise on matters of compliance, regulatory requirements and Pfizer regulatory policy.
* NRA queries and requests for local label updates).
* Input to assessing regulatory impact, agree filing strategy with other business functions as appropriate and participate in risk-based reviews with above-country hubs and communicate any locally triggered delays & risks impacting the submission/approval, to the above and in-country stakeholders.




* Management of NRA queries* In partnership with above-country operational hubs and above-country strategists, respond to NRA queries.Develop and enact appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues.
* Utilise local knowledge of NRA's expectations, ways of working etc to appropriately direct company strategy.

Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.
* Work with authorities if Pfizer position differs from authority position in order to obtain a better outcome for the business/patients.
* Populate and Maintain Regulatory Databases
* Perform database entry and the document management for regulatory transactions undertaken by Country Strategists, in line with general SOPs. Safeguard Compliance and Manage Packaging and Prescribing Information Component updates* Via defined procedures notify relevant internal stakeholders of NRA approval of changes to packaging components and prescribing information and the timelines for associated implementation activities.
* Support MA Divestments, MA Cancellations, product Discontinuations and Supply ContinuityWorking with local stakeholders and above country operational Hubs, where applicable:Divestments: Advise business on regulatory activities required prior to divestment/transfer of licence.

Liaise with local Commercial/Medical/Demand functions and advise on regulatory action required for discontinuation of a product in the country marketplace.

Support Third Party Licences**
* Manage relevant, local regulatory activities related to supporting third party licences for which Pfizer has a contractual oblig

📌 Compliance Lead (Ciudad de México)
🏢 Pfizer
📍 Ciudad de México