Regulatory Specialist ( MSR)

Regulatory Specialist, MSR Coordination

Market Specific Requirements (MSR) within Global Regulatory Centre is accountable for the delivery of all Market Specific Requirements (MSRs) across Global Regulatory Affairs (GRA) across the lifecycle in support of regulatory submissions for Pharma and Vaccines organization.

The purpose for the role will be timely maintenance of Market Specific Requirements (MSRs) in support to various applications. Senior Regulatory Specialist is accountable for delivering MSRs documentation in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licenses and new applications worldwide.

You will have an opportunity to work closely with GRC’s internal and external stakeholders according to agreed ways of working, priorities and deadlines to ensure delivery of overall GRC’s goals.

• Managing Market Specific Requirements for Finished Products and Active Pharmaceutical Ingredients in various areas
• Complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets
• Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time
• Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements
• Understand external/internal Regulatory environment.
• Building good relationships with internal and external stakeholders.

Requirements:

• Knowledge of worldwide CMC regulatory requirements ( preferred)
• Work experience in an international environment would be an additional advantage
• Relevant experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance)
• Bachelor’s or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field
• Attention to detail, excellent organization and time management skills
• Excellent written and verbal communication skills in English and Polish
• Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes

What we offer:

• Career at one of the leading global healthcare companies. 
• Replacement Contract of employment ( until FEB 2025)
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit). 

• Life insurance and pension plan. 
• Private medical package with additional preventive healthcare services for employees and their eligible. 
• Sports cards (Multisport). 
• Possibilities of development within the role and company’s structure. 
• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training). 

• Extensive support of work life balance (flexible working solutions, health & well-being activities). 
• Supportive community and integration events. 
• Modern office with creative rooms, fresh fruits every day

#LI-GSK

#LI-HYBRID

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origi