Site Name: Poznan Grunwaldzka, Warsaw

Posted Date: Apr 17 2025

Regulatory Project Manager – CMC Technical Writing

Responsible for incorporating regulatory strategies into regulatory submission documents and ensuring such documents are written and managed to team/project expectations and conform to the regulatory and company standards. Individual may be responsible either for a single product or multiple products.

Key Responsibilities include, but are not limited to:

• Develop submission plans and contribute to the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects
• Collaborate with CMC regulatory lead to provide regulatory support for assigned projects
• Communicate with Regulatory Operations on the planning of global Clinical Trial Applications, marketing applications and post-approval supplements and variations
• Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA)
• Prepare and coordinate the review and approval of submission-ready documents
• Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
• Review submission documents to ensure messaging is clear and consistent within and across documents, and to perform a final copyediting check
• Work collaboratively with CMC regulatory colleagues and SMEs to interpret and summarize complex data
  
  
  

Required Skills and Qualifications:

• Degree in life sciences or related scientific discipline
• Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
• Thorough understanding of global regulations and ICH guidance pertaining to pharmaceutical development and lifecycle management of NCE/NME products
• Experience preparing CMC sections of IND/IMPDs, BLA/NDA/MAAs, and supportive clinical amendments and post approval supplements/variations. (ICH Modules 2 and/or 3)
• Thorough understanding of change management processes and regulatory requirements.
• Strong problem solving and diplomacy skills.
• Excellent project management skills
  
  
  

Why GSK?

• Career at one of the leading global healthcare companies
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Hybrid working model (where GSK site are in Poland)
• Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working form the office, short Fridays option, health & well-being activities)
• 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)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits every day
  
  
  

Inclusion at GSK:

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [email protected] to discuss your needs.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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