Senior Regulatory Specialist, Small Molecules, CMC, Global Regulatory Affairs – Delivery Team
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Poznan • Poland
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Salary
💰 PLN 144,750 - PLN 241,250 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsCMC variationstechnical documentationICH CTD documentationActive Pharmaceutical Ingredients (APIs)drug developmentchange managementsubmission-ready documentsproject managementquality assurance
Soft Skills
attention to detailflexible thinkinganalytical thinkinginterpersonal skillscommunication skillsmentoringtrainingcollaborationproblem-solvingtime management