Regulatory Specialist, Renewals

What we are doing?

Global Regulatory Centres (GRC) in GSK are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, licence maintenance and lifecycle management dossiers, and regulatory information management. The Global Regulatory Centres provide regulatory support across the product lifecycle for pharmaceutical, biopharm and vaccines products (clinical development to market maturity).

Renewals CMC Team (Chemistry, Manufacturing, and Controls) is part of GRC and plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use. Team is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. While the science is our main area we are also working with technology to perform at our best as we operate in a fast-paced and evolving environment.

Your Responsibilities:

• Supporting digital transformation through active participation in building digital skills

• Evaluating and implementing innovative solutions for CMC Regulatory processes, policies and systems

• Managing multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products including response to questions from Agency

• Define and agree regulatory strategy, complete data assessment to ensure CMC dossier authored in compliance with Company regulatory processes and external requirements for international markets

• Effective communication also in a digital context, including virtual meetings and digital platforms

• Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time

• Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements

• Act as subject matter expert in regulatory processes

Why you?

We are looking for professionals with these required skills to achieve our goals:

• Software and System Experience: Power BI, Excel, SharePoint; hands-on experience with Gen AI

• Relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation)

• Min. bachelor’s degree in Life Sciences, Chemistry, Health Sciences, or related fields

• Mindset that embraces digital transformation and innovation through adaptability, forward-thinking, and exploring new possibilities in the ever-evolving digital landscape

• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.

• Attention to details, excellent organization and time management skills

• Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.

• Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts

• Veeva Vault knowledge would be an asset

Why GSK?

We also offer a wide range of additional benefits:

• Performance with Choice – flexibility in working mode - hybrid work, flexible working hours, possibility of working from abroad up to 30 days a year

• Established job in an international, well-known biopharma company

• Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets

• Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)

• Recognition awards for additional achievements

• Supportive & friendly working environment with integration events

• Possibilities of development within the role and company’s structure with personalized learning approach (mentoring, coaching, online training’ platforms)

• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)

• Modern office with creative rooms, fresh fruits every day

• Free car and bike parking, locker rooms and showers.

Inclusion & Diversity at GSK: 

As an employer committed to Diversity and Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at [email protected] to discuss your needs.

#LI-GSK

#LI-HYBRID

#LI-DEI

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/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.