Combination Product & Regulatory Compliance Specialist (m/f)

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 Control