Senior Regulatory Specialist, Delivery Lead, GRA Vaccine CMC Mature Products

Senior Regulatory Specialist Delivery Lead GRA Vaccine CMC Mature Products

At GSK were 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 thats where our CMC Delivery teams experience and support are crucial.

We are currently seeking Senior Regulatory Specialist (Delivery Lead)to join our GRA Vx Mature CMC 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.

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.

Key Responsibilities include

As aSenior Regulatory Specialist (Delivery Lead) you will:

• Take ownership for complex CMC regulatory submissions including planning coordination and execution to support applications for marketing authorizations lifecycle activities and maintenance of registered products across Vaccines portfolioin accordance withthe applicable regulatoryand scientificstandards.
• 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 Leadsteam Global Supply Chain (GSC) Quality Assurance (QA) Local Operating Companies (LOCs) and third Parties in order to build regulatoryCMCsubmissions 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 while sharing best practices to build capability and knowledge within the CMC Regulatory teamsand other impacted functions.

Required Skills and Qualifications

Were seeking professionals who bring:

• Advanced degree (Masters or above) in Pharmacy Biotechnology Biology Chemistry/Biochemistry or other closely related medical/life science field.
• Relevant experience in CMC Regulatory Affairs within pharmaceutical industry or research organization (minimum 3 years)
• Proven expertise in regulatory dossier preparation (CTD Module 1-3) technical dossier review and in all associated CMC regulatory aspects.
• Understanding of the pharmaceutical industry drug development environment regulatory processes and ICH guidelines and requirements including EU regulatory framework.
• 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:

• Performance with Choice flexibility in working mode (hybrid working model 2/3 days per week in the office) flexible working hours.
• Established job in an international well-known pharmaceutical company.
• Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets.
• Opportunity to work within GSK standards and documentation applied globally.
• Wide range of benefits (Medical Plan Life Insurance Employee Retirement Program Sport and recreation cards Recreation allowance annual bonus).
• Supportive & friendly working environment.

Were looking for someone who thrives in a collaborative environment is passionate about delivering results and is eager to make a difference. If this sounds like you wed love to hear from you!

If you require any adjustments during the recruitment process feel free to contact our Recruitment Team at

#LI-GSK #LI-HYBRID

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 were 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.

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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Senior IC