Regulatory Specialist
- Kazakhstan - Almaty
Use Your Power for Purpose
At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the dynamic regulatory environment demands forward-thinking and meticulous attention to detail. Your work will ensure that our documentation processes are efficient and compliant, ultimately contributing to the timely delivery of life-saving medicines and vaccines to those in need.
What You Will Achieve
In this role, you will:
- Manage an efficient documentation system, ensuring compliance with regulatory requirements and maintaining record retention and information services.
- Interpret documentation standards, policies, and operating procedures, identifying submission components, and coordinating the assembly of regulatory dossiers.
- Maintain continuous contact with local, regional, and divisional customers, keeping up-to-date with product information and regulatory changes.
- Explain complex issues and establish consensus within the team through effective communication skills.
- Inform relevant internal stakeholders about the regulatory authority's approval of changes to the packaging component for assigned products to ensure their timely and accurate implementation.
- Provide guidance and supervise the operations team in preparing documents, particularly on technical aspects such as product specifications and certificates of analysis.
- Review all documents and dossiers related to submissions of new product registration, line extensions, post-approval changes, and license renewals, ensuring compliance with local regulatory requirements.
- Support the Regulatory Affairs Lead and Managers in the timely preparation of reports, perform data entry and quality control tasks, and keep the Safety team informed of adverse events according to relevant SOPs.
Here Is What You Need (Minimum Requirements)
- BA/BS with at least 2 years of experience or MBA/MS with any years of experience
- Demonstrated experience in Regulatory Affairs or a related function within the pharmaceutical sector
- Proven ability to oversee and provide Quality Control support
- Strong knowledge of National and Clinical Trials legislation and guidelines
- Ability to interpret and relay technical information accurately
- Proficiency in English, both verbal and written
- Proficiency in computer and software applications
Bonus Points If You Have (Preferred Requirements)
- A Master's degree with relevant pharmaceutical experience
- Experience in managing documentation systems within a regulatory environment
- Familiarity with global regulatory requirements and submission processes
- Strong analytical and problem-solving skills
- Excellent organizational and time management skills
- Ability to work independently as well as collaboratively within a team
- Adaptability and flexibility in a dynamic work environment
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Breakthroughs 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)