Senior Regulatory Specialist, Small Molecules, CMC, Global Regulatory Affairs
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Warsaw • 🇵🇱 Poland
Visit company websiteSalary
💰 PLN 131,250 - PLN 218,750 per year
Job Level
Senior
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.
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
regulatory affairsCMC regulatory proceduresICH CTD documentationtechnical documentationchange management processesActive Pharmaceutical Ingredientsdrug developmentpharmaceutical industry knowledgeattention to detailaccuracy and completeness
Soft skills
mentoringtraininginterpersonal skillscommunication skillsflexible thinkinganalytical thinkingability to handle multiple tasksmeeting shifting prioritiesscheduling workbuilding relationships
Certifications
Bachelor’s degreeMaster’s degree