Regulatory Specialist, MSR Coordination

Site Name: Poznan Grunwaldzka Posted Date: Dec 16 2022 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 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. Find out more: Annual Report 2021 We are now looking for a Regulatory Specialist, MSR Coordination to join our Polish Hub. Regulatory Specialist, MSR Coordination Market Specific Requirements (MSR) within Global Regulatory Centre is accountable for the delivery of all Market Specific Requirements (MSRs) across Global Regulatory Affairs (GRA) across the lifecycle in support of regulatory submissions for Pharma and Vaccines organization. The purpose for the role will be timely maintenance of Market Specific Requirements (MSRs) in support to various applications. Regulatory Specialist is accountable for delivering MSRs documentation in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licenses and new applications worldwide. You will have an opportunity to work closely with GRC’s internal and external stakeholders according to agreed ways of working, priorities and deadlines to ensure delivery of overall GRC’s goals. Managing Market Specific Requirements for Finished Products and Active Pharmaceutical Ingredients in various areas Complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets 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 Understand external/internal Regulatory environment. Building good relationships with internal and external stakeholders. Requirements: Knowledge of worldwide CMC regulatory requirements ( preferred) Work experience in an international environment would be an additional advantage Relevant experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance) Bachelor’s or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field Attention to detail, excellent organization and time management skills Excellent written and verbal communication skills in English and Polish Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues Understanding of the pharmaceutical industry, drug development environment, and regulatory processes What we offer: 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. Modern office with creative rooms, fresh fruits every day.
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LI-HYBRID Inclusion & Diversity at GSK: Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career. GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant. We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ([email protected]) to further discuss this today. We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application. 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.