As a Senior Regulatory Specialist, you'll be responsible for ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business. You'll collaborate with diverse teams to produce high-quality components for global regulatory dossiers and have the opportunity to mentor and train 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
- Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.
- Established job in an international, well-known pharmaceutical company.
- Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets.
- Opportunity to work within GSK standards and documentation applied globally.
- Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).
- Supportive & friendly working environment.
