Senior Regulatory Specialist, Regional Projects Team GlaxoSmithKline
Employer Active
Posted 17 hrs ago
Send me Jobs like this
Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Within the CMC RA group, the Regional Projects team bring together the operation and execution aspects for key regulatory deliverables for new Directives and Guidelines issued in Regions such as the implementation of eCTD Baselining, general Baselining, Localisation initiatives, and Re- Registrations. The Regional Projects team provide regulatory support across the Regions to deliver Submissions as stipulated in the new HA Directives for pharmaceutical, biopharm and vaccines products.
These responsibilities include some of the following:
- Manage multiple CMC (Chemistry, Manufacturing and Controls) regional project assignments for Pharma and Vaccines products, handling varied complexity and routinely delivering on more complex tasks.
- Define and agree regulatory strategy independently and confidently for assigned projects.
- Complete data assessments to ensure CMC dossiers are authored in compliance with company regulatory processes and external requirements for international markets.
- Identify regulatory risks related to submission data and information packages and take appropriate action to mitigate them.
- Escalate issues with potential business impact to the line manager, proposing practical solutions.
- Maintain up-to-date knowledge of regulations, guidelines, procedures and policies related to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications.
- Identify and recommend improvements to regulatory processes, policies and systems.
- Provide expert consultation and practical solutions in specialist areas; act as a subject matter expert.
- Mentor and train new staff, sharing expertise and best practices.
- Communicate effectively across channels, including virtual meetings and digital platforms.
- Collaborate with Global Manufacturing & Supply and GSK Local Operating Companies worldwide to deliver high-quality dossiers on time.
- Monitor the internal and external regulatory environment and act proactively on identified changes to requirements.
- Support digital transformation initiatives by actively participating in building digital skills and adopting new digital tools.
Desired Candidate Profile
Basic Qualification
- Bachelor s degree in Pharmacy, Chemistry, Biotechnology or a related scientific or technical field.
- Minimum 3 years of relevant regulatory affairs experience, including CMC submissions or post-approval variations.
- Practical knowledge of Common Technical Document (CTD) Module 2 and 3 content and dossier structure.
- Strong written and verbal communication skills in English.
- Proven ability to manage multiple projects and meet deadlines.
- Attention to detail and commitment to deliver high-quality work.
Preferred Qualification
- Master s degree or higher in a relevant scientific discipline.
- Experience in an international regulatory environment or working with multiple markets.
- Familiarity with European regulatory requirements and ICH guidelines.
- Experience with electronic document systems or eCTD platforms.
- Track record of improving regulatory processes or supporting digital initiatives.
- Experience mentoring others and building effective cross-functional relationships.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Senior Regulatory Specialist
- Regional Projects Team
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
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. We re uniting science, technology, and talent to get ahead of disease together./p>