Send me Jobs like this
Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Senior Regulatory Specialist, Small Molecules Mature Products, CMC, Global Regulatory Affairs Delivery Team
Join the Delivery Team within SMMP at GSK and play a crucial role in global Chemistry, Manufacturing, and Control (CMC) variation projects and Global Supply Chain (GSC) change programs for pharmaceutical products. You ll be responsible for ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business. You ll be responsible for preparing technical documentation for global regulatory changes, responding to Regulatory Agency inquiries, and providing expert guidance on CMC variations for Active Pharmaceutical Ingredients (APIs), Intermediates, and Drug Products.
In this role, you ll collaborate with diverse teams across Global Regulatory Organization, Global Supply Chain, Quality Assurance, Contract Manufacturing Organizations, and the Office of the Chief Medical Officer (OCMO) to produce high-quality components for global regulatory dossiers. Additionally, you ll have the opportunity to mentor and train new team members, contributing to the growth and success of the team.
In this role you will
- Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Pharma products (working with the CTD Module 3, Quality section of the dossiers).
- Managing assigned projects by executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and in compliance with GSK regulatory processes and external requirements for local markets (e.g., Europe, US, and International countries), and identifying risks associated with submission data and information packages.
- Preparing and coordinating the review and approval of submission-ready documents.
- Collaborating with Product Owners/Project Managers to provide regulatory support for assigned projects.
- Working with colleagues in the Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies in markets worldwide to deliver high-quality dossiers on time.
- Building and maintaining strong relationships with internal and external stakeholders.
- Monitoring regulatory intelligence and proactively acting on identified changes to regulatory requirements.
- Identifying improvement opportunities for CMC regulatory processes, policies, and systems.
Desired Candidate Profile
Basic Qualifications & Skills:
We are seeking professionals with the following required skills and qualifications to help us achieve our roles:
- Bachelor s or Master s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.
- Relevant experience in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).
- Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
- Thorough understanding of change management processes and regulatory requirements.
- Attention to detail with an emphasis on accuracy and completeness.
- Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.
- Flexible and analytical thinking to independently provide solutions to issues.
- Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.
- Excellent written and verbal communication skills in English.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Senior Regulatory Specialist
Disclaimer: Naukrigulf.com is only a platform to bring jobseekers & employers together. Applicants are advised to research the bonafides of the prospective employer independently. We do NOT endorse any requests for money payments and strictly advice against sharing personal or bank related information. We also recommend you visit Security Advice for more information. If you suspect any fraud or malpractice, email us at abuse@naukrigulf.com
GlaxoSmithKline
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.