Labelling Regulatory Manager, Country Labelling

Site Name: Poznan Grunwaldzka, Warsaw Posted Date: Jan 31 2023 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. The Country Labelling Manager is accountable for leading and managing the team responsible for delivering local labelling submissions and management of global labelling documents in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licenses worldwide. Country Labelling Manager cooperates with colleagues in clinical, safety and other regulatory functions according to agreed ways of working, priorities and deadlines to ensure delivery of overall Departmental goals. In your new role as the Country Labelling Manager you will: manage people aspects of a team of direct reports to create and sustain an efficient and motivating working environment support global/country/regional labelling in compliance with GSK Labelling processes and external requirements act as subject matter expert in GSK Labelling process identify risks to quality and/or timely completion of project, resolving any issues and escalating items to be resolved at a higher management level participate in projects and activities, such as identifying areas for improvements/efficiencies and leading implementation of changes to labelling processes build and maintain quality relations with your internal and external stakeholders work closely with your peers and manager to drive standardization across the business Basic qualifications: proven experience in regulatory area, labelling experience is preferred higher education in life sciences/ pharmacy sound understanding of pharmaceutical industry, drug development environment and regulatory processes well-developed understanding of labelling (e.g. significant experience in managing local labelling documents/submissions and/or management of global labelling documents) strong interpersonal and communication skills and ability to present information in a clear and concise manner ability to perform multiple tasks, set the right priorities to deliver objectives on time adaptable to changing circumstances through priorities reassessment and a disciplined, logical work style fluent English and Polish (both verbal and written) Preferred qualifications: well-developed leadership skills negotiation and problem solving skills project management and team management experience would be an asset At GSK we offer a wide range of additional benefits:  Career at one of the leading global healthcare companies 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.  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
LI-GSK
LI-HYBRID 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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.