Laura Clachar

Regulatory Sciences Manager (Portfolio Team Lead and Projects Team Lead)

Responsibilities as Portfolio Team leader overseeing internal medicine, inflammation, and hospital portfolio for CAC Region.

· Lead and manage the GRA team under my responsibility, overseeing the development of regulatory strategies to support the registration of new products, line extensions, major variations, and lifecycle management. Ensure that local GRA team provide strategic regulatory input, offering optimal support for meeting local business objectives as needed.

· Build strong partnerships with in-country teams (such as Country Brand Lead, Medical, Marketing, Supply Chain, Safety) and Regional Regulatory Teams to facilitate the creation and implementation of registration strategies, expediting the approval of new products, line extensions, and lifecycle optimization.

· Deliver strategic contributions at the country level by anticipating the regulatory needs required to achieve business objectives.

· Direct the development, leadership, and performance management of the GRA team to accomplish company goals. Strengthening the capabilities and capacities of GRA team by identifying and fulfilling training and development requirements.

· Establish and enhance relationships with key external agencies. Oversee interactions with Health Authorities/Boards of Health throughout the development and lifecycle of products under my responsibility. Foster long-term, positive relationships characterized by integrity, quality, compliance, and leadership. Serve as the primary liaison and contact local government regulators regarding all regulatory affairs activities.

· Ensure the maintenance of licenses (such as Marketing Authorizations) in accordance with local regulations by implementing corporate regulatory processes, SOPs, and systems (including CMC change control, product labelling, etc.). Guarantee that both permanent and contract local RA staff are fully trained in these procedures.

· Ensure all regulatory activities (such as new product submissions and maintenance of existing licenses) comply with local regulations, requirements, and practices.

· Maintain a high level of expertise and understanding of each applicable local regulation. Ensure the local regulatory team receives thorough training on all relevant regulations and that internal databases are consistently updated.

Responsibilities as Project Team Lead include overseeing all major legal entity name changes, holder transitions, and enhancements to local systems for CAC Region.

· Lead and coordinate project execution to ensure timely delivery within defined scope, budget, and company policies.

· Develop, implement, and monitor detailed project plans, proactively identifying and mitigating risks.

· Maintain accurate project documentation, including progress reports, spreadsheets, diagrams, and process maps.

· Ensure data accuracy and regulatory compliance in company databases and systems.

· Promote continuous improvement and innovation through participation in regulatory initiatives and ongoing training.

· Report project status and escalate issues to management as needed, supporting a culture aligned with corporate values.

Pfizer Regional Regulatory Hub Strategist/ RRHS Brexit Lead for Latam markets.

Responsibilities as Regional Regulatory Hub Strategist for CAC Markets, overseeing the PIH portfolio.

· Demonstrate comprehensive knowledge and effective application of Hub procedures.

· Collaborate with CMC, Submissions Management, Cluster/Market teams, and other key stakeholders to ensure all BoH requirements are fulfilled.

· Prepare and manage regulatory submissions within assigned responsibilities, guaranteeing full compliance with BoH requirements.

· Execute regulatory strategies—including timelines—in line with the agreed approach from primary stakeholders (such as the Global Regulatory Team, PGS, Markets, Clusters, Labeling team, Submissions Management, and CMC) to ensure submission-ready dossiers.

· Coordinate with manufacturing sites to obtain necessary supporting documentation.

· Utilize submission planning and forecasting tools to update timelines as required.

· Review submission packages for consistency and completeness, ensuring alignment with local BoH requirements.

· Promptly update the regulatory requirements systems and databases when market regulations change.

· Contribute to both local and regional regulatory initiatives, fostering a culture that supports Pfizer values, compliance, innovation, and the development and retention of talent, as needed.

· Serve as the main point of contact for the LATAM Oncology portfolio and RTAL, providing required reports to cluster leads and the PCO team.

Responsibilities as RRHS Brexit Lead for Latam markets (secondment)

· Lead and coordinate the execution of Brexit-related regulatory projects, ensuring timely delivery and compliance with company standards.

· Define project scope, objectives, and deliverables in collaboration with stakeholders to guarantee feasibility and alignment.

· Develop and implement detailed project plans, tracking progress and milestones throughout the project lifecycle.

· Manage changes to project scope, timeline, and budget, applying verification techniques to maintain control.

· Monitor and analyze project performance using appropriate tools, ensuring full regulatory compliance.

· Identify and address project risks, communicating effectively with management and proposing solutions.

· Maintain comprehensive documentation, including spreadsheets, diagrams, and process maps to support project needs.

· Assign tasks to team members based on their strengths and expertise, fostering collaboration and accountability.

· Regularly report project status to sponsors and direct managers, escalating issues as necessary.

· Promote a culture of compliance and innovation, contributing to regulatory initiatives and continuous improvement.

· Lead and coordinate regulatory project and product registration strategies, overseeing submission and execution across 14 countries within the Pfizer Central America and Caribbean cluster.

· Ensure full compliance of all regulatory documentation with both regional and international standards.

· Drive and execute activities to achieve commercial goals related to product renewals, transfers, institutional tenders, post-approval changes, and country-specific registration processes.

· Supervise and guide the Regulatory Affairs Officer, aligning responsibilities with current strategies and ensuring timely submission and approval of dossiers.

· Facilitate cross-functional collaboration with Supply Chain, Logistics, and Business Operations teams, implementing regulatory strategies to secure uninterrupted business continuity throughout the product lifecycle.

· Collaborate with Marketing and Commercial teams to define and execute optimal regulatory strategies for promotional materials.

· Manage AQRT-related activities in accordance with procedures established by the Regulatory Affairs Manager.

· Lead and coordinate regulatory project and product registration strategies, overseeing submission and execution across 14 countries within the Pfizer Central America and Caribbean cluster.

· Ensure full compliance of all regulatory documentation with both regional and international standards.

· Drive and execute activities to achieve commercial goals related to product renewals, transfers, institutional tenders, post-approval changes, and country-specific registration processes.

· Supervise and guide the Regulatory Affairs Officer, aligning responsibilities with current strategies and ensuring timely submission and approval of dossiers.

· Facilitate cross-functional collaboration with Supply Chain, Logistics, and Business Operations teams, implementing regulatory strategies to secure uninterrupted business continuity throughout the product lifecycle.

· Collaborate with Marketing and Commercial teams to define and execute optimal regulatory strategies for promotional materials.

· Manage AQRT-related activities in accordance with procedures established by the Regulatory Affairs Manager.

· Provide comprehensive support to manufacturers regarding all requirements for renewal processes and post-registration changes, ensuring full compliance with local and regional regulations.

· Review technical and legal documents meticulously to guarantee their alignment with current regulatory standards.

· Plan and coordinate the availability of necessary documents (technical and legal) and samples required for renewals and post-registration modifications.

· Ensure precise preparation of dossiers and timely submission to the relevant Regulatory Authorities.

· Oversee and follow up on renewal applications and post-registration changes submitted to Regulatory Authorities, maintaining accurate records and timelines.

· Liaise effectively with Regulatory Authorities to resolve contingencies and secure approval for renewals and post-registration changes within the anticipated approval timeframe.