• Leads cross functional submission working groups to deliver successful new drug applications and line extensions to international Health Authorities through effective Project Management leadership, oversight, and planning.• Partners with program Global Regulatory Lead, to plan, deliver and oversee Regulatory goals and submissions in accordance with regulatory strategy for highly complex programs.• Successfully understands implications of product strategy; partners to develop regulatory strategy by designing and assessing regulatory strategy options on a regional and global basis. • Provides expert guidance on global regulations to ensure regulatory compliance and obtain earliest possible approval, leading to successful market entry.• Engages senior leaders to escalate, inform, influence, resolve issues that may impact submission builds or the logistics of submission delivery to regional partners or Health Authorities.• Keeps abreast of evolving industry trends, allowing the company to adapt quickly to changes in the regulatory landscape.• Cultivates strong relationships with organization leadership and key stakeholders, facilitating open communication channels.• Promotes professional development through mentoring and motivating junior team members and colleagues; matrix manages cross-functional collaborations for key projects, fostering strong working relationships among team members.• Cross trains existing employees to maximize team agility and performance.• Serves as a major source of innovative ideas, developing efficiencies by collaborating with key contributors and business partners; leads lessons learned sessions to implement change.• Leads complex process improvement projects, making decisions independently and collaborating with stakeholders and regulatory leaders.• Redesigns submission processes and workflows by identifying bottlenecks; proactively address challenges leading to improved efficiency and timely approvals from regulatory agencies.

• Operate as regulatory operational Subject Matter Expert for a product and drive submission teams towards the timely delivery of globally and regionally compliant submission-ready components and successful compilation of dossiers.• Provide an interface to Regulatory partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory submissions to regional partners and selected Health Authorities.• Submission Management leader and change agent exhibiting regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor.• Successfully navigate complex regulations for various types of pharmaceutical products from application through to approval and lifecycle.• Collaborate with cross-functional teams to ensure alignment on regulatory requirements and timelines.

• Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate. Partner with product teams and/or third-party partners in support of regional and national regulatory submissions component build and delivery.• Coordinated and organized information and maintained regulatory documentation databases in compliance with regulatory requirements. Ensured all regulatory documentation was compliant with Standard Operating Procedures (SOP’s) for format, content, and storage.• Lead the interpretation of regulatory guidelines to produce business requirements and ensure implementation of those requirements at local level.• Managed risk assessments and mitigations, resulting in a reduction of potential compliance issues; Lead Lessons Learned sessions and implements change.• Contribute to effective forecasting and management of project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.• Adhere to the appropriate use of technical tools, through use of working practices and QC/QA teams to ensure regulatory and internal compliance is preserved.• Provide day-to-day direction to Publishing Managers so that dossiers can be prepared and managed appropriately throughout Pfizer processes and systems. • Upload finalized documents into the eCTD submission manager to create a final submission copy.

*Build electronic and paper submissions for busy Regulatory Affairs department*Manage activities associated with the submission of regulatory documentation to FDA with most emphasis on safety reports*Interpreting electronic and paper submission guidance and specifications*Establish compliant folder structure, file and folder metadata and index/XML backbone, i.e. publishing softwarePrepare final submission including printing, assembly and binding*Perform quality review to ensure adherence to regulatory guidelines and other applicable specifications related to submissions*Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents

Manage regulatory submission dossiers meet regulatory guidelines and timelinesAbility to comprehend, implement new trends in pharmaceutical submission-related processes, state-of-the-art toolsLeverage submission process technologies, such as electronic document repository, submission publishing tools, and electronic archival systemProvide exceptional customer service by developing a method for project completion, prioritizing conflicting priorities, and delivering quality product on timeAbility to persuade and motivate people from all levels of the organization to achieve a goal or outcome and create an effective change in the group's performance

Key interface between client company point of contact and perspective job talent to identify and effectively strategize staffing challenges and solutionsDevelop strong working relationships to align resource needs and skill sets of talentEffectively recruit, retain and coach employees for temporary and career positions; ensure the contracted employees fully understand the requirements of the job function are clear, and expectations are evidentMarket employees' skills, knowledge and abilities to assist them in reaching their professional goals

Prospect and develop new accountsNew product development; initiate and manage promotion programs and sales materialsDevelop and manage marketing budgets

Coordinate review process for study reports

Provide administrative support to president and recruiters; assuring strict attention to administrative detailsPrepare and track various promotional projects including advertising and newsletters

Develop and implement a curriculum for a class of 24 childrenSupervise team of early childhood professionals