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Experience
3 - 5 Years
Education
Bachelor of Science(Biology), Bachelor of Pharmacy(Pharmacy)
Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
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 a Senior 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 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 in order 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, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions.
Desired Candidate Profile
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.
- 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)
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Senior Regulatory Specialist
- Delivery Lead
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GlaxoSmithKline
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./p> We are currently seeking Senior Regulatory Specialist (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. 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.