Regulatory Manager Team Lead### Regulatory Manager Team Lead申请: Mexico
- Mexico City: 全职: 今天发布: 4966523Work Location Assignment: Mexico City, Mexico. Must be able to work from assigned Pfizer office 3 days per week, or as needed by the business. JOB SUMMARYLead, manage and provide strategic direction to their regulatory team in assigned markets. Manage assigned projects at a cluster level; provide strategic regulatory input into cross-functional product teams for pre
- and post-authorisation product lifecycle activities working with above country operational hubs on operational activities. 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.
* Leading role implementing effective and efficient processes in the cluster/country.
* 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.
* Deputise for Head of Regulatory Sciences for the cluster/country as required.



## 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 regulatory team members work effectively in a productive and well-motivated environment through providing ongoing coaching, guidance and sharing of regulatory expertise.
* 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.
* Participate in the recruitment of new staff as required.
* 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.
* Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.
* Work with above country regulatory strategists to provide country specific input into General and Regional regulatory strategies as required.
* Ensure alignment of local and regional regulatory strategy and tactics. Provide Regulatory Advice and Information to meet Customer and cross-divisional colleague requests.* Use expert knowledge of national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customers.
* Advise on matters of compliance, regulatory requirements and Pfizer regulatory policy.
* Use a variety of communication tools and techniques to present complex ideas.
* Anticipate potential objections and influence others. Manage New Registration/Marketing Authorization Applications:National Applications* Coordinate pre-submission meetings and other National Regulatory Authority (NRA) engagements, such as EU national Scientific Advice Meetings.
* Devise and obtain endorsement for submission strategy and plan and partner with above-country operational hubs and above-country strategists to obtain new product licenses. Manage associated interactions and negotiations with NRAs.Manage Marketing Authorisation (MA) Variation Applications* Trigger locally driven submission demands (e.g. NRA queries and requests for local label updates).
* Input to assessing r

📌 Regulatory Manager Team Lead (Ciudad de México)
🏢 Pfizer
📍 Ciudad de México