Are you looking for an opportunity to work on global projects and make a meaningful impact in the pharmaceutical industry?
Join the Delivery Team within SMMP as a Senior Regulatory Specialist and play a pivotal role in driving global Chemistry, Manufacturing, and Control (CMC) variation projects and Global Supply Chain (GSC) change programs for pharmaceutical products.
As a Senior Regulatory Specialist, you will take on a key role in ensuring the timely and efficient delivery of regulatory activities across multiple CMC projects within the Pharma business. Your responsibilities will include preparing technical documentation for global regulatory changes, responding to inquiries from Regulatory Agencies, and providing expert guidance on CMC variations for Active Pharmaceutical Ingredients (APIs), intermediates, and drug products.
In this role, you will collaborate cross-functionally with diverse teams within the Global Regulatory Organization, Global Supply Chain, Quality Assurance, Contract Manufacturing Organizations, and the Office of the Chief Medical Officer (OCMO) to contribute to the development of high-quality components for global regulatory dossiers. Additionally, you will have the opportunity to mentor and train new team members, fostering their growth and driving the success of the team.
Key Responsibilities include, but are not limited to:
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.
Basic qualifications:
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.
What we offer:
Career with purpose - whatever it is you’re doing, you’ll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer.
Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund, preventive healthcare services).
Hybrid working model ( 2/3 days per week in the office).
Career at one of the leading global healthcare companies.
Supportive & friendly working environment.
Corporate culture, based on being Ambitious for patients, Accountable for Impact and Doing the right thing, which powers our purpose, drives delivery of our strategy and helps make GSK a place where people can thrive.
#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 special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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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