rio execution hub ManagerPfizer

Use Your Power for PurposeAt Pfizer, we are committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer's medicines and vaccines.What You Will AchieveIn this role, you will:Assist in the preparation, publication, tracking, and quality control of regulatory submissions, ensuring compliance with document management standardsCoordinate activities related to enterprise-wide regulatory management systems and provide guidance on moderately complex projectsApply skills and discipline knowledge to contribute to departmental work, making decisions to resolve moderately complex problems and developing new optionsWork independently on assignments, seeking directional review for unusual or complex problems, and review the work of colleagues in a mentor roleGuide operational teams in managing projects, preparing resource forecasts, and identifying areas for improvement in products, processes, or servicesAct as a point person for regulatory agency interactions, including preparation of briefing packages and strategy for meetings, inspections, and responses to agency lettersUnderstand and challenge scientific arguments, identify regulatory scientific data needs, and solve regulatory issues to influence the development of new global products and improvements to existing productsManage registrations of existing customer products in compliance with applicable regulations and support global team efforts to ensure high-quality, compliant submissionsProvide daily regulatory support to Global Product Development teams and lead the logistics involved with regulatory Clinical Trial Application (CTA) submissionsManage the preparation of registration packages, responses to deficiency letters, and suggest system improvements to reduce cycle time and increase efficiencyHere Is What You Need (Minimum Requirements)BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experienceDemonstrated experience in regulatory affairs, research and development, or quality assurance/complianceExperience working directly with regulatory agenciesStrong knowledge of the drug development process, regulatory affairs, CTA, and submissions managementSound knowledge of applicable portions of agency guidance documents and regulationsAbility to exercise good judgment within company policy and health authority regulations with good negotiation skills.Excellent written and interpersonal communication skillsBonus Points If You Have (Preferred Requirements)Master's degree with relevant pharmaceutical experience, particularly in the lifecycle management of approved applications.Proven ability to manage multiple projects and deadlinesProficiency in regulatory submission software and toolsExcellent organizational and time management skillsStrong attention to detail and accuracyPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs
Pfizer

Makati City, Metro Manila
Permanent
Full-time