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Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
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
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.
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.
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).
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Regulatory Project Manager
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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. 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.