We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – 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.
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.
We are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer’s medicines and vaccines.
What You Will Achieve
In this role, you will :
- Provide strategic product direction and interact with regulatory agencies to expedite approval of pending registrations.
- Represent regulatory interests to marketing, research project teams, and government agencies throughout the product lifecycle.
- Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports.
- Provide input to stakeholders for product development in line with business objectives, ensuring strategies are reflected in country plans and aligned with regulatory activities and commercial goals.
- Support the development of Regulatory Affairs by maintaining internal databases, tracking systems, and document management, and offering regulatory inputs for promotional material approval.
- Oversee clinical trial applications, manage queries and commitments with stakeholders, and ensure manufacturing and packaging projects are approved on time, maintaining licenses in compliance with local regulations.
Here Is What You Need (Minimum Requirements)
High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA / BS with 2+ years of experience or MBA / MS with any years of relevant experienceDemonstrated experience in regulatory affairs or in a regulated industryIn-depth knowledge of the current health regulatory framework for drug regulatory proceduresStrong problem-solving skills, attention to detail, and a quality and compliance orientationExcellent verbal and written communication skills, and fluent in EnglishProficient in MS Office SuiteBonus Points If You Have (Preferred Requirements)
A Master's degree along with relevant pharmaceutical experienceFamiliarity with electronic submission processes and regulatory information management systemsAbility to work effectively in a fast-paced, dynamic environmentStrong interpersonal skills and the ability to work collaboratively with cross-functional teamsExcellent organizational and time management skillsAbility to adapt to changing priorities and manage multiple tasks simultaneouslyStrong analytical skills and the ability to interpret complex regulatory guidelines and requirementsPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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.Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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