Regulatory Specialist – Submission Delivery Excellence
Job Category: Regulatory Affairs
Employment Type: Full-Time
Job Locations: Poznan, Poland | Bengaluru, India
Job ID: 434141
Work Model: Hybrid (location-specific)
Posted Date: January 28, 2026
About GSK
GSK is a global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. With a strong focus on innovation in specialty medicines and vaccines, GSK aims to positively impact the health of billions of people worldwide. The organization operates across key therapeutic areas including respiratory, immunology, oncology, HIV, and infectious diseases.
Job Overview
The Regulatory Specialist – Submission Delivery Excellence plays a critical role in supporting global regulatory submission activities. This position works closely with global submission teams and local regulatory contacts to ensure timely, compliant, and high-quality regulatory submissions across multiple markets, in alignment with regulatory authority requirements and GSK standard operating procedures.
This role offers strong exposure to global regulatory processes and provides opportunities for professional growth within Regulatory Affairs.
Key Responsibilities
Deliver global marketing authorization applications and lifecycle management submissions, including product renewals, site registrations, renewals, and variations, within agreed timelines.
Coordinate Module Submission Readiness (MSR) activities and execute agreed dossier strategies independently.
Manage end-to-end coordination, preparation, and delivery of regulatory registration samples in collaboration with manufacturing sites, third-party service providers, central teams, and local operating companies.
Identify, assess, and escalate regulatory submission risks with potential business impact.
Apply regulatory guidelines, policies, and procedures related to pharmaceutical product registration and manufacturing to ensure efficient submission delivery.
Support regulatory authority submissions and post-approval maintenance activities, including PBRER submissions.
Participate in continuous process improvement initiatives to enhance submission efficiency and compliance.
Mentor and support junior team members as required.
Lead or co-lead cross-functional submission team meetings, facilitating discussions on timelines, resource planning, and risk management.
Required Qualifications & Experience
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Healthcare, or a related scientific discipline.
Minimum 3–6 years of relevant experience in Regulatory Affairs, regulatory submissions, or submission delivery within the pharmaceutical or biopharmaceutical industry.
Strong understanding of global pharmaceutical regulatory frameworks and submission processes.
Ability to interpret and apply regulatory guidelines and legislation accurately.
Experience working in a matrix, cross-functional, and international environment.
Proven ability to manage multiple priorities, shifting timelines, and complex regulatory activities.
Strong written and verbal communication skills with attention to detail.
Demonstrated capability in risk identification, issue escalation, and stakeholder management.
Experience mentoring or guiding team members is an advantage.
Compensation & Benefits
Competitive base salary aligned with local market standards.
Annual performance-based bonus eligibility.
Flexible and hybrid working options (role and location dependent).
Learning, training, and career development opportunities.
Access to healthcare, wellbeing, and employee support programs.
Additional statutory and location-specific benefits as applicable.
Work Arrangement
This is a hybrid role with regular in-office presence, particularly for the Poland location. Final working arrangements will be agreed upon with the hiring manager based on business and team requirements.
Diversity & Inclusion
GSK is an Equal Opportunity Employer and is committed to creating an inclusive recruitment process. Applicants from all backgrounds are encouraged to apply. Reasonable accommodations are available throughout the recruitment process.
How to Apply
Interested candidates are encouraged to apply through the official application process. Shortlisted applicants will receive further details regarding compensation, benefits, and next steps during the recruitment process.
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