Senior Regulatory Specialist ( CTA/IND)

Site Name: Poznan Grunwaldzka, Warsaw Posted Date: Jan 8 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 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 SENIOR REGULATORY SPECIALIST ( CTA/ IND) to join our Polish Hub. Key Responsibilities: Coordination, development, refinement of the CTA/IND lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures. Accountable to the functional CTA/IND Team Lead for overall work plans and accountable to individual GRLs/TGs for study submission planning & delivery status. Accountability for agreed tasks and projects. Ensure independent communication, with a range of internal GSK staff, in support achievement of the assigned goals. Ensure quality of both own and submission team’s work, delivering to agreed timeframes, including compliance with GSK systems and record keeping. Provide input to internal processes and written standards. To work flexibly to meet constant shifting priorities and timelines. May provide support to other activities within the CTA/IND and/or Content Delivery Team. Why You? What skills and expertise you will bring to the role: Min. Bachelor’s degree in biological or healthcare science (Chemistry, pharmacy, other related science or regulatory affairs). Relevant experience within Regulatory Affairs in the R&D, pharmaceutical industry or clinical trials. Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. A good understanding of Clinical Trial Directive, DIA Trial Master File Reference Model and CTA/IND submission requirements for multiple countries/submission types. Well-developed interpersonal and communication skills to work in a matrix environment effectively and build good working relationships in cross-functional teams. Written and verbal communication skills in English and Polish, ability to present information in a clear and concise manner. Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams. Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines. Ability to work in multiple IT systems (filing, tracking & repositories). Mentoring experience would be an advantage. Veeva Vault experience would be an advantage. 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. Modern office with creative rooms, fresh fruits every day.
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.