RIO Execution Hub Manager
- Philippines - Makati City
Use Your Power for Purpose
At 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 Achieve
In this role, you will:
Assist in the preparation, publication, tracking, and quality control of regulatory submissions, ensuring compliance with document management standards
Coordinate activities related to enterprise-wide regulatory management systems and provide guidance on moderately complex projects
Apply skills and discipline knowledge to contribute to departmental work, making decisions to resolve moderately complex problems and developing new options
Work independently on assignments, seeking directional review for unusual or complex problems, and review the work of colleagues in a mentor role
Guide operational teams in managing projects, preparing resource forecasts, and identifying areas for improvement in products, processes, or services
Act as a point person for regulatory agency interactions, including preparation of briefing packages and strategy for meetings, inspections, and responses to agency letters
Understand 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 products
Manage registrations of existing customer products in compliance with applicable regulations and support global team efforts to ensure high-quality, compliant submissions
Provide daily regulatory support to Global Product Development teams and lead the logistics involved with regulatory Clinical Trial Application (CTA) submissions
Manage the preparation of registration packages, responses to deficiency letters, and suggest system improvements to reduce cycle time and increase efficiency
Here 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 experience
Demonstrated experience in regulatory affairs, research and development, or quality assurance/compliance
Experience working directly with regulatory agencies
Strong knowledge of the drug development process, regulatory affairs, CTA, and submissions management
Sound knowledge of applicable portions of agency guidance documents and regulations
Ability to exercise good judgment within company policy and health authority regulations with good negotiation skills.
Excellent written and interpersonal communication skills
Bonus 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 deadlines
Proficiency in regulatory submission software and tools
Excellent organizational and time management skills
Strong attention to detail and accuracy
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory AffairsBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)