![9605 GSK Services Sp z o.o.](https://media.trabajo.org/img/noimg.jpg)
Senior Regulatory Specialist, New Registration CMC
2 tygodni temu
What we are doing?
Global Regulatory Centres (GRC) in GSK are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, licence maintenance and lifecycle management dossiers, and regulatory information management. The Global Regulatory Centres provide regulatory support across the product lifecycle for pharmaceutical, biopharm and vaccines products (clinical development to market maturity).
New Registration CMC Team (Chemistry, Manufacturing, and Controls) is part of GRC and plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use. Team is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. When the science is our main area we also work with technology to perform at our best as we operates in a fast-paced and evolving environment.
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 assetWhy GSK?
We also offer a wide range of additional benefits:
Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs), flexible working hours, possibility of working from abroad up to 30 days a year Established job in an international, well-known biopharma company Opportunity to work in professional team playing important role in introducing and GSK portfolio on the markets Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus) Recognition awards for additional achievements Supportive & friendly working environment with integration events Possibilities of development within the role and company's structure with personalized learning approach (mentoring, coaching, online training' platforms) Extensive support of work life balance (flexible working solutions, health & well-being activities) Modern office with creative rooms, fresh fruits every day Free car and bike parking, locker rooms and showers.#LI-GSK
#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.
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.
-
Regulatory Specialist, Product Variations
2 tygodni temu
Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etatSite Name: Poznan Grunwaldzka, WarsawPosted Date: Nov Global Regulatory Centres in GSK are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, licence maintenance and lifecycle management dossiers, and regulatory...
-
Regulatory Specialist
2 tygodni temu
Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etatSite Name: Poznan Grunwaldzka, WarsawPosted Date: Jun 7 2024Regulatory Specialist supports operational activities related to maintenance of marketing authorisations (MAs) across assigned markets and/or submission types in European Partnership Markets, working in close collaboration with country leads, as well as global regulatory teams/centers and local 3rd...
-
Regulatory Affairs Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Smith & Nephew Pełny etatRegulatory Affairs Specialist page is loaded Regulatory Affairs Specialist Apply locations POL - Warsaw time type Full time posted on Posted 6 Days Ago job requisition id R74567 Life Unlimited.At Smith+Nephew we design and manufacture technology that takes the limits off living. The Regulatory Affairs Specialist is responsible for representing and...
-
Senior Regulatory Affairs and Quality Assurance Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Stryker Pełny etatAre you looking for a career opportunity at a renowned company where you can engage in diverse projects and collaborate across various functions? Joining Stryker's Regulatory Affairs/Quality Assurance (RAQA) team offers you continuous learning prospects and ample room for professional growth. If you seek to be a part of a globally recognized workplace, take...
-
Lead Regulatory Strategist – Biologics Manufacturing
4 tygodni temu
Warszawa, Mazovia, Polska Danaher Pełny etatBe part of something altogether life-changingWorking at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...
-
Lead Regulatory Strategist – Biologics Manufacturing
2 miesięcy temu
Warszawa, Mazovia, Polska Danaher Pełny etatBe part of something altogether life-changingWorking at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...
-
Regulatory Affairs Specialist
2 tygodni temu
Warszawa, Mazovia, Polska HAYS POLAND Sp. z o.o. Pełny etatRegulatory Affairs Specialist / Associate Manager Warszawa, mazowieckie Regulatory Affairs Specialist / Associate Manager Warszawa Warszawa, Mazowieckie, Polska Regulatory Affairs Specialist / Associate Manager Warszawa Warszawa, Mazowieckie, Polska For our client, a global FMCG company, we are looking for a Regulatory Affairs Specialist / Associate...
-
Associate Director, Regulatory Process
2 tygodni temu
Warszawa, Mazovia, Polska AstraZeneca Pełny etatWorking closely with the Processes Directors, the main responsibility of this role is to manage assigned AstraZeneca projects and processes, focusing on CMC variation process and its contribution to Regulatory Business Processes. Key tasks include: Identifying and enhancing existing processes through knowledge of internal and external environment. ...
-
Senior Regulatory Specialist, Country Labelling
2 tygodni temu
Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etatSite Name: Warsaw, Poznan GrunwaldzkaPosted Date: May The Senior Regulatory Specialist, Country Labelling is responsible for effective coordination, communication and maintenance of regional/country labelling documents (for multiple markets/regions) and data in regulatory systems in accordance with defined standards and processes. You will provide support to...
-
Senior Regulatory Affairs Specialist/Manager
2 tygodni temu
Warszawa, Mazovia, Polska HAYS POLAND Sp. z o.o. Pełny etatSenior Regulatory Affairs Specialist/Manager Warsaw, Masovian Voivodeship Job Responsibilities: 1. Stay up-to-date with evolving regulatory requirements in Europe, particularly for medical devices. 2. Offer expert regulatory advice for strategic decision-making, ensuring effective execution of regulatory strategies. 3. Manage maintenance activities and...
-
Regulatory Affairs Consultant- MAAs
1 tydzień temu
Warszawa, Mazovia, Polska Parexel Pełny etatWe are seeking a highly motivated and experienced Regulatory Affairs Consultant (MAAs) to join our team. As a Regulatory Affairs Consultant, you will provide operational regulatory support for assigned programs and activities. This role can be office or home based in various European locaitons.Job Responsibilities: Coordinate with other groups within...
-
Regulatory Scientist
2 tygodni temu
Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etatManpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i...
-
Intern, Regulatory Affairs
2 tygodni temu
Warszawa, Mazovia, Polska SC Johnson Pełny etatIntern, Regulatory Affairs Assistant to Regulatory and Registration Manager Location: Warsaw Overview The purpose of an internship is to provide real-world experience that enables the intern to put everything he/she learned into action. An internship can help the candidate gain skills that can be applied to future jobs. As an Intern, Regulatory...
-
Regulatory Affairs Manager CEE
2 tygodni temu
Warszawa, Mazovia, Polska Galderma Pełny etatDescriptionKey ResponsibilitiesTake the lead in developing and executing regulatory strategies for CIS and non-EU CEE countries, ensuring timely submissions of high quality.Oversee the entire registration process, including approvals for new products, manufacturing and import permits, and product amendments.Assist distributors in engaging and negotiating...
-
Regulatory Affairs Consultant
6 dni temu
Warszawa, Mazovia, Polska Parexel Pełny etatWe are looking for a Consultant Regulatory Affairs for Labeling. This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based).In this role you will partner with Label Strategist to:Conduct international labeling operations activities to support global new product and supplemental applications to product...
-
Warszawa, Mazovia, Polska Management Solutions, SL Pełny etatManagement Solutions | Envío de CV y ofertas de empleo User registration| Login Private area How to apply English Español Português United States NEW TECHNOLOGIES AND DIGITAL TRANSFORMATION CONSULTAN NEW YORK New York / Internship / Number of vacancies: 2 You will be working in key projects for leading organizations in IT strategy and governance...
-
Senior Regulatory Specialist, CTA/IND
2 tygodni temu
Warszawa, Mazovia, Polska 9605 GSK Services Sp z o.o. Pełny etatWe 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...
-
Senior Manager Regulatory Operations
2 tygodni temu
Warszawa, Mazovia, Polska Hobson Prior Pełny etatHobson Prior is seeking a Senior Manager for Regulatory Operations. This role will be the primary contact for Regulatory Affairs in business projects that involve or impact data, systems, and processes. The successful candidate will ensure data compliance, accuracy, and usability, and will also provide support and training for the relevant community. This...
-
Regulatory Affairs Systems Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Zimmer Biomet Pełny etatValued Team member: We are glad you are exploring new opportunities within Zimmer BiometWhat You Can ExpectAs a Regulatory Affairs Specialist for systems team, you provide support for the maintenance and implementation of RA systems, with a particular focus on Regulatory Information Management System (RIMS) and Regulatory Distribution Controls through SAP...
-
Regulatory Submission Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Publicis Le Pont Pełny etatJob DescriptionAs a Regulatory Submission Specialist, in this role, you will be tasked with delving into medical documents, pinpointing the correct references for pharmaceutical marketing materials, uploading content onto the Veeva Vault platform, and overseeing internal processes and project management. This position is ideal for individuals with top-notch...