포스팅 날짜: Apr 11 2025
Senior Regulatory Specialist, New Registration CMC, CMC Excellence
The CMC Regulatory Affairs group at GSK is located across multiple sites and plays a crucial role in ensuring the approval and continuous supply of medicines. Within the CMC RA group, the New Registrations CMC team bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity, product expansion dossiers and CTA submissions. The New Registrations CMC team provide regulatory support across for development and registration of new pharmaceutical, biopharm and vaccines products.
Your Responsibilities:
- Managing multiple CMC new files and CTA assignments for Pharma, Biopharm and Vaccines products including response to questions from Agency;
- Define and agree regulatory strategy, complete data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements;
- 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;
- Effective communication also in a digital context, including virtual meetings and digital platforms;
- Act as subject matter expert in regulatory processes;
- Evaluating and implementing innovative solutions for CMC Regulatory processes, policies and systems;
- Supporting digital transformation through active participation in building digital skills;
Why you?
We are looking for professionals with these required skills to achieve our goals:
- Extensive experience in regulatory affairs, pharmaceutical industry (familiarity with CMC regulatory procedures and ICH CTD documentation)
- Bachelor’s or Master’s degree in biotechnology, pharmacy, chemistry or other related science or technical field
- 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.
- Understanding of the pharmaceutical industry, drug development environment and regulatory processes.
- Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts
- Mindset that embraces digital transformation and innovation by being adaptable, forward-thinking, and eager to explore new possibilities in the ever-evolving digital landscape
- Veeva Vault knowledge would be an asset
Why GSK?
At GSK we offer a wide range of additional benefits:
- Career at one of the leading global healthcare companies
- Hybrid work ( 2/3 days per week from the office)
- Contract of employment
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
- Life insurance and pension plan
- Private medical package with additional preventive healthcare services for employees and their eligible counterparts.
- Sports cards (Multisport)
- Possibilities of development within the role and company’s structure
- Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
- Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).
- Supportive community and integration events
- Modern office with creative rooms, fresh fruits every day
#LI-GSK
#LI-HYBRID
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/