Regulatory Specialist Job At GSK
GSK is hiring a Regulatory Specialist – Submission Delivery Excellence to support global regulatory submissions across multiple markets. This Regulatory Affairs Job role offers hands-on exposure to end-to-end regulatory submission delivery, lifecycle management, and collaboration with global regulatory teams while ensuring compliance with international regulatory requirements. Graduates seeking Pharmacy Jobs and want to start their career in Pharmacy Careers can apply now.
Job Details
- Job Title: Regulatory Specialist – Submission Delivery Excellence
- Locations: Poznan (Poland) | Bengaluru (India)
About the Company
GSK is a global biopharma company focused on uniting science, technology, and talent to get ahead of disease together. With innovation across vaccines and specialty medicines, GSK aims to positively impact the health of billions worldwide through responsible science and patient-centric solutions. This Regulatory Affairs Job role plays a significant role in the company.
Educational Requirements
- Degree in Pharmacy
- Extensive experience in Regulatory Affairs
Key Responsibilities
- Deliver marketing applications and lifecycle maintenance submissions within agreed timelines
- Manage product renewals, site registrations, variations, and PBRER submissions
- Coordinate MSR and execute dossier strategies independently
- Plan and coordinate regulatory registration samples with manufacturing sites and partners
- Identify, assess, and escalate regulatory submission risks
- Interpret and apply global regulatory guidelines to expedite submissions
- Participate in process improvement initiatives
- Support cross-functional submission teams and maintenance activities
- Mentor and train junior team members as required
Skills Required
- Strong understanding of pharmaceutical regulatory affairs and R&D processes
- Ability to interpret and apply regulatory requirements
- Excellent stakeholder management and communication skills
- Strong organizational skills with high attention to detail
- Risk identification, mitigation, and escalation capabilities
- Ability to lead or co-lead multidisciplinary submission meetings
- Flexibility to manage changing priorities and timelines
Regulatory Exposure
- Global Regulatory Authorities
- Marketing Authorization Applications
- Lifecycle Management Submissions
- PBRER and Regulatory Maintenance Activities
- Graduates seeking Pharmacy Jobs and want to start their career in Pharmacy Careers can apply now.
