Combination Product & Regulatory Compliance Specialist (m/f)
- Croatia - Zagreb
This is a maternal leave replacement position in Savski Marof.
JOB SUMMARY
This role is deeply involved in the quality system for combination products and is the liaison between the site and Worldwide Safety and Regulatory (WSR) and Global Technology and Engineering (GTEL), Design authority.
The role works collaboratively with Regulatory colleagues to determine when the Regulatory Change Management Process is required and prepares documentation for regulatory submissions and other regulatory documents to regulatory agencies.
This role works closely with Design authority colleagues to determine when the Design Change is required and maintains Design Development File for combination products.
JOB RESPONSIBILITIES
Quality System for Combination Products
- Participate in activities related to Quality System for Combination products
Design and Regulatory Change Management
- Perform design and regulatory impact assessment by comparing the current information in Design Development File and registered information with the proposed change to determine if Design or Regulatory Change is required. As needed, collaborate with GTEL and Regulatory colleagues.
- Review the regulatory requirements or guidelines to evaluate possible regulatory requirements
- As needed, determine best case and worst case BOH approval timelines, align with Regulatory colleagues on timelines as needed, and share high-level estimation of the BOH approval timelines with the site
- As needed, collect the current registered information or request them from Regulatory colleagues
- Share the preliminary market regulatory impact assessment with the site
- For changes impacting multiple sites, ensure that impacted sites are being informed of the proposed changes and obtain their concurrence prior to the competition of impact assessment
- Coordinate collection of regulatory supporting documents for the change control and registration as needed
- initiate the Product Change Form (PCF) in PDM system to clearly specify the change from and to with justification, products impacted, specific markets impacted where the change will not impact all markets, other impacted sites, and upload the supporting documents by the agreed timeline and route the PCF for Global CMC Market Impact Assessment.
- Communicate the Market Impact Assessment (MIA) feedback from Global CMC to the site
- Track regulatory submission status and approvals within PDM and communicate to the site
- Support Global CMC in completion of BOH queries, inform the site and obtain the required documentation from the site to support the BOH queries.
- Inform the site when specific markets are authorized to be implemented, when a BOH approval is received, any BOH commitment made.
- If required, participate in the investigation of issues related to the change controls.
License Renewal, Product Launch, License Withdrawal, and Tenders
- Support License Renewals, Product Launches, License Withdrawals and Tender applications following the same approach as above.
Ancillary Documents and Samples
- Support generation and collection of ancillary documents and samples (finished product, labels, etc.), if required.
Audits and Inspections
- Support audits and inspections as required.
QUALIFICATIONS / SKILLS
Problem Solving:
- efficiently maintain Registration and Design control documentation, make improvements as necessary.
Accountability:
- Accountable for accuracy of work and meeting multiple, simultaneous deadlines.
Analytical Ability:
- Able to follow scientific arguments and identify design and regulatory scientific data needs.
Authority to Act:
- Prepare accurate and timely documentations that are in compliance with all applicable regulations.
- Participate in team meetings and coordinate activities with department and team members.
- Act independently on most routine issues, make judgment and execute.
BASIC QUALIFICATIONS
- University degree - pharmacy, biology, biotechnology, chemistry or a related subject is required.
- More than 2 years of experience in either pharmaceutical or device company.
WHAT WE OFFER
Hybrid work arrangements
Organized transport to and from the site
Work with modern automated systems
Strong education program
Christmas, Easter and holiday bonus
Affordable meals in an on-site cafeteria
Opportunities for career enhancement and development
Yearly pay increase and bonus based on performance
Further professional development in a supportive environment
Free health check-ups
Free psychotherapy and coaching sessions for employees and people close to them
Bravo employee recognition system
Opportunity for working on projects with other Pfizer sites and locations
Free fruit and hot beverages on the site
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and ControlBreakthroughs 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)