Regulatory Project Manager

Business Introduction

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.

 

Role purpose

The CMC Mature Vx Delivery Lead plays a critical role in supporting registered vaccines products by managing complex CMC submissions (such as CMC Post-approval variations, Health Authorities consultations or responses to Health Authorities questions). This includes addressing regulatory requirements for Active Pharmaceutical Ingredients, Intermediates, and Drug Products across global markets. Through his/her expertise in CMC regulatory requirements and dossiers preparation, the CMC Mature Vx Delivery Lead is ensuring the quality and accuracy of CMC-related information.

The role of Regulatory Project Manager (Delivery Lead) creates an opportunity to lead initiatives that drive efficiency and innovation, ensuring continuity of supply for life-saving medicines and making a tangible difference for patients.

You will take on a key role in ensuring the timely and efficient delivery of regulatory activities across multiple CMC projects within the Vx business. You will collaborate cross-functionally with diverse teams within the Global Regulatory Organization, Global Supply Chain, Quality Assurance, Contract Manufacturing Organizations to contribute to the development of high-quality components for global regulatory dossiers. Additionally, you will have the opportunity to mentor and guide new team members, fostering their growth and driving the success of the team.

 

 Key Responsibilities include

As a Regulatory Project Manager (Delivery Lead), you will:

• 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.

 

Required Skills and Qualifications

We’re seeking professionals who bring:

• 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).

The annual base salary in Poland for new hires in this position ranges from PLN 183,750 to PLN 306,250 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.

Why GSK?

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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