Verona, Verona, Italy
22 hours ago
Regulatory Affairs Operations and Artworks Officer
Site Name: Italy - Verona Posted Date: Jan 23 2025 We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK Scope: He/she is responsible for managing the creation/updating of the printed components for the finished product/samples/Medical Devices/Promo Devices in line with the needs of product launches, with registration variations, in order to ensure continuity of supply. He is responsible, with the qualification of Champion Record Retention, for the correct archiving of the Management's documentation, both paper and electronic. He/she is responsible for ensuring, in support of the Product Regulatory Specialist Manager, the correct and efficient management of regulatory activities necessary to obtain product marketing authorization and ensure their maintenance In this role, you will… Coordinate the creation and modification of printed materials and artwork for products, considering timing, urgency, stock levels, and priorities, collaborating closely with Licensing and Business Development for Licensing Market products. Provide APS/Production Site with all necessary graphic and regulatory details for artwork creation (artwork brief). Interface with internal and external bodies for proof-reading, Braille translation, and stamp activities, and update the graphics of Poligrafico stamps. Collaborate with Regulatory Specialists for the timing of regulation implementation, extensions, or exceptions, and with Marketing for relevant graphic aspects. Interface with Co-marketer Companies for technical, graphic, and regulatory aspects in collaboration with Licensing and Business Development, and manage German texts for databases. Enter new product entries and disposals in the MyPRS/MySKU Group system, monitor KPIs of artwork processes, perform self-inspections for inspection readiness, and support Regulatory Specialists when necessary. Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor's or Master's degree in chemistry/biology or a degree in a scientific field (e.g., Pharmacy, Biotechnology). Previous experience in a similar role within pharmaceutical companies. Knowledge of sector-specific regulations and laws, including corporate Ethical & Legal Compliance, and Italian and European regulatory regulations for product and printed material registration. Good knowledge of the English language and computer systems, including proficiency in PowerPoint, Word, and Excel. Experience with AI technologies in operational or analytical workflows and expertise in Power BI, including dashboard creation. Proficiency in artwork management systems like GLAMS, and knowledge of industry standards and regulations (e.g., GxP, EMA). What we offer: Permanent contract in a very Inclusive environment Smart Working up to 50% for eligible roles Performance Reward Flexible Benefits Company Healthcare Plan Integrative pension fund Employee Assistance Programme Personal parcel delivery service Local nursery agreement Free Company canteen Coffee Corners Closing Date for Applications – 7 febbraio 2025 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. #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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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.
Confirm your E-mail: Send Email