Regional Clinical Trial Submission Manager
- Korea, Republic of - Seoul
JOB SUMMARY
The CTRSE Regional Submission Manager, is accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics, leading project management activities for Clinical Trials, across multiple TAs, Phases and Markets. The CT RSM Provides an interface to GSSO partners, offering project leadership and expertise in the strategic and operational execution of regulatory Clinical Trial Application (CTA) submissions to regional partners and selected Health Authorities/Central Ethics Committees. This role will focus on the CTA submissions in China and other APAC countries.
The Clinical Trial Submission Manager (CT-SM) is accountable for working with contributing business lines to lead submissions execution timelines for designated CTAs. They may operate as regulatory Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components. The CT-SM is required to author & deliver customized documentation for selected submissions across multiple markets.
The CT-SM may be assigned as a Global Submission Manager to meet business demands. In this capacity, they may operate as Subject Matter Expert for a selected geography.
JOB RESPONSIBILITIES
Drives Regional submission management activities for their assigned protocols. Partners with global Submission and Portfolio Manager, GSSO lines and/or third-party partners, with responsibility for representation and management of required regulatory and Central Ethics activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographies.
Support and leads Regional and global efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
Liaises with GSSO, regarding essential documents that cross both HA and EC submission and translation processes driving compliance and timely delivery,
Prepare, review and submit submissions to HA/Regional CTA, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
Manages the compilation for submission build, contributing to CTA & CE approvals and authoring documentation as required. Responsible for the co-ordination of translations for local documents required for submission.
Acts as Subject Matter Expert for CTRSE and provides country-level intelligence on clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the CTR team, is maintained on the central repository, e.g. Competent Authority submission requirements.
Promotes professional development through mentoring and motivating colleagues.
Provides guidance to and leads CTA submissions and process improvement projects, making decisions independently.
Drives communication and proposes refinements through collaboration with stakeholders and regulatory leaders. Serves as Pfizer CTRSE representative with Health Authority meetings, Industry discussions/ initiatives.
Contributes to changes in policies and strategies to meet evolving business needs.
Self-initiates assignments, developing innovative ideas to resolve complex problems and leading the execution of projects.
QUALIFICATIONS / SKILLS
SKILLS
Significant knowledge of the drug development process, Regulatory Sciences and submission management and publishing.
Demonstrated understanding of regional and national regulator filing guidelines and dossier requirements.
Demonstrated ability to lead and deliver through others in a matrix model.
Demonstrated ability to deliver swift decisions in ambiguous or urgent circumstances.
Robust organizational management skills.
Advanced knowledge of the processes, systems and regulatory guidance and a detailed understanding/knowledge of principles and concepts of other disciplines.
Proven ability to embrace new technologies and processes and drive their implementation.
QUALIFICIATIONS
A degree in Pharmacy, Life Sciences, Business or Information Technology; Minimun 6 years’ experience in clinical trials; equivalent relevant professional experience will be considered.
Comprehensive understanding of ICH/GCP guidelines, as well as CTA regulations and process in China and other APAC countries.
In-depth understanding and proven execution of CTA processes globally.
Proven technical aptitude and ability to quickly learn and use new software, regulations, and quality standards.
Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
Fluent in both written and spoken English.
Worker Type:
Regular
Work Location Assignment: Hybrid
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.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
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)