Regulatory Project Manager Job at GSK (Poznan)

Regulatory Project Manager

GSK

Location:
Poland , Poznan ▼
Warsaw

Category:
IT - Administration

Contract Type:
Not provided

Salary:

236250.00 - 393750.00 PLN / Year

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Job Description:

At GSK, we’re constantly developing new products and improving our established medicines to improve the quality of human life by enabling people to do more, feel better and live longer. Ensuring all changes for Finished Product and Drug Substance are properly registered and up to date is essential, and that’s where our CMC Delivery team’s experience and support are crucial. We are currently seeking Regulatory Project Manager (Delivery Lead) to join our GRA Vx Mature CMC team. In this role, you will be involved in impactful initiatives, drive operational efficiency, and foster innovation, contributing to the delivery of life-saving vaccines to patients worldwide.

Job Responsibility:

Take ownership for multiple complex CMC regulatory submissions, including planning, coordination and execution, to support applications for marketing authorizations, lifecycle activities and maintenance of registered products across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards
Manage multiple project assignments simultaneously, including CMC variations and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers)
Identify risks associated with submission data and information package
and support the development of mitigation strategies
Collaborate closely with cross-functional teams, such as Global Regulatory Lead’s team, Global Supply Chain (GSC), Quality Assurance (QA), Local Operating Companies (LOCs), and third Parties to build regulatory CMC submissions and maintain strong relationships, including with senior stakeholders
Identify improvement opportunities for CMC Regulatory processes, policies, instructions and systems, developing and implementing simplified working practices and procedures to enhance efficiency and quality
Serve as Subject Matter Expert (SME) for CMC Regulatory Affairs, mentoring and guiding team members, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions

Requirements:

Advanced degree (Master's or above) in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field
Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization
Extensive expertise in regulatory strategy planning, dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects
Sound understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework
Exceptional flexibility, analytical thinking and growth mindset
Excellent interpersonal skills
including clear and effective written and verbal communication, and the ability to build strong relationships across a diverse, large organization
English writing skills
Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness)

What we offer:

private healthcare
additional paid days off
life insurance
private pension plan
fully paid parental leave & care of family member leave

Additional Information:

Job Posted:
January 16, 2026

Employment Type:

Fulltime

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