Hybrid Senior Regulatory Specialist, Small Molecules, CMC, Global Regulatory Affairs – Delivery Team

at GSK

• Job title: Senior Regulatory Specialist, Small Molecules, CMC, Global Regulatory Affairs – Delivery Team
• Job type: Full Time
• Experience level: Senior
• Salary: PLN 144,750 - PLN 241,250 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Poznan, Poland

About the role

• Senior Regulatory Specialist ensuring timely and efficient delivery of regulatory activities across various CMC projects for GSK. Collaborating with diverse teams and mentoring new members in a hybrid role in Poland.

Responsibilities

• Ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business.
• Preparing technical documentation for global regulatory changes.
• Responding to Regulatory Agency inquiries.
• Providing expert guidance on CMC variations for Active Pharmaceutical Ingredients (APIs), Intermediates, and Drug Products.
• Collaborating with diverse teams across Global Regulatory Organization, Global Supply Chain, Quality Assurance, and Contract Manufacturing Organizations.
• Mentoring and training new team members.
• Managing multiple project assignments including CMC variations, source transfers, and Health Authority Questions (HAQs).
• Preparing and coordinating the review and approval of submission-ready documents.

Requirements

• Bachelor’s or Master’s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.
• Relevant experience in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
• Thorough understanding of change management processes and regulatory requirements.
• Attention to detail with an emphasis on accuracy and completeness.
• Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.
• Flexible and analytical thinking to independently provide solutions to issues.
• Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.
• Excellent written and verbal communication skills in English.

Benefits

• Medical Plan
• Life Insurance
• Employee Retirement Program
• Sport and recreation cards
• Recreation allowance
• Annual bonus