Regulatory Project Manager

2 tygodni temu

Warszawa, Mazovia, Polska 9605 GSK Services Sp z o.o. Pełny etat

We are looking for an ambitious Regulatory Project Manager to ensure the development of regulatory strategy(ies) and their execution for assigned asset(s) consistent with the strategic activities for GSK's Classic & Established Product (CEP) portfolio. This goal must be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements.

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

In this role you will

Act as Global Regulatory Lead to drive matrix team engagement for a range of CEP portfolio Assets and take ownership of for the life cycle maintenance, including discontinuation of Marketing Authorizations (MAs), including Lead communication with regulatory agencies, specifically be the main point of contact with the European Medicines Agency and other European Local Health Authorities for National, Centralised and Mutual Recognition procedures products. Ensure that the regulatory strategy delivers the needs of the Global and regional commercial and supply chain projects, while considering the regulatory needs of the local market(s). Cultivate and sustain productive relationships with internal stakeholders, including regulatory labelling, CMC, medical, commercial, supply chain, and clinical teams. Take proactive initiatives, demonstrating a keen ability to identify and escalate crucial issues early and actively contribute to crafting solutions. Ensure compliance with global/regional regulatory life-cycle requirements (e.g., renewals, label updates, aggregate safety reports etc) and delivery of health authority commitments.

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

Degree in Biological or Healthcare Science Experience of all phases of the drug development process in regulatory affairs, with particular emphasis on maintenance and lifecycle management of marketed products In depth understanding and practical experience of European Regulatory landscape and procedural requirements, guidelines and working practices is a must Knowledge of licensing requirements in other regions (APAC, LATAM, MENA) and experience with such Agencies is desirable Capable of being able to develop product / therapeutic knowledge in new area Ability to work in a complex environment Good communication and influencing skills. Capable of delivering key communications with clarity, impact and passion

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

Ability to foster strong matrix working, facilitating dialogue between team and matrix members to contribute their ideas especially working remotely and in a virtual context with stakeholders Developing personal networks within GSK and capable of using them to secure appropriate support and outcome for a project Capable of identifying project or team issues in advance and seeking necessary help and support to resolve Ability to use a range of sources and weigh benefits and risks before making important decisions Focus on improving performance and excellence by challenging the ways of working and capable of developing and recommending strategies for change. Understands regulatory governance, medical and safety

Why 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 Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat

    Site Name: Poznan Grunwaldzka, WarsawPosted Date: Jun We are looking for an ambitious Regulatory Project Manager to ensure the development of regulatory strategy(ies) and their execution for assigned asset(s) consistent with the strategic activities for GSK's Classic & Established Product (CEP) portfolio. This goal must be achieved while ensuring compliance...

  • Senior Project Manager, Regulatory Labelling

    2 tygodni temu

    Warszawa, Mazovia, Polska ICON Pełny etat

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • Regulatory Affairs Manager CEE

    2 tygodni temu

    Warszawa, Mazovia, Polska Galderma Pełny etat

    Galderma is a leading company in dermatology, present in around 90 countries, delivering innovative products and services for the skin.We are seeking individuals who are committed to achieving results, love learning, and radiate positive energy. Our ideal candidates show initiative, teamwork, and a passion for making a meaningful difference for consumers and...

  • Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Link Group Pełny etat

    Project Manager (Regulatory & Compliance) - Remote @ Link Group Warszawa Warsaw, Masovian Voivodeship, Polska Required Skills & Experience:Proven experience in effective project management, with 3 to 5 years in regulatory or compliance fields.Results-driven with strong analytical skills, capable of handling technical activities.Confident in leading digital...

  • Senior Regulatory Affairs Specialist/Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska HAYS POLAND Sp. z o.o. Pełny etat

    Senior 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...

  • Operations Manager Clinical Regulatory Writing

    2 tygodni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Be encouraged and supported to think creatively in our dynamic...

  • Regulatory Affairs Manager CEE

    2 tygodni temu

    Warszawa, Mazovia, Polska coty Pełny etat

    Regulatory Affairs Manager CEEWarsawCoty is a leading beauty company globally, showcasing a portfolio of renowned brands in fragrance, cosmetics, and skincare. With products distributed in over 150 countries, Coty is dedicated to various social causes and environmental sustainability.ROLE AND DEPARTMENTWe are seeking a Regulatory Affairs Manager to join our...

  • Senior Manager Regulatory Operations

    2 tygodni temu

    Warszawa, Mazovia, Polska Hobson Prior Pełny etat

    Hobson 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...

  • Senior/Technical Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Leap29 Pełny etat

    Job Title: Senior/Technical Project Manager - Renewable EnergyIntroduction: We are seeking an experienced Technical Project Manager (this role can be Senior Technical Project Manager depending on years of experience) to lead our client's renewable energy initiatives in Poland, with a focus on photovoltaic (PV) technologies and BESS. As the Technical Project...

  • Regulatory Affairs Specialist

    2 tygodni temu

    Warszawa, Mazovia, Polska HAYS POLAND Sp. z o.o. Pełny etat

    Regulatory 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...

  • Clinical Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Alimentiv Inc. Pełny etat

    As the primary sponsor liaison and advocate, the Clinical Project Manager will plan, execute, manage and monitor regional, single modality or therapeutic area clinical research projects. Utilizing existing templates, processes and programs as a guide, he or she will adapt/develop, implement, monitor and be accountable for project protocols, operational...

  • Manager Procesów Operacyjnych/Operations Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska HR Project Pełny etat

    Manager Procesów Operacyjnych/Operations Manager, WarszawaAktualnie dla naszego klienta z branży finansowej poszukujemy osoby na stanowisko Managera Procesów Operacyjnych/Operations Manager. Praca w biurze w Warszawie.Obowiązki:Opracowywanie i wdrażanie działań mających na celu optymalizację procesów oraz udoskonalenie jakości obsługi klienta w...

  • Senior Manager Regulatory Operations

    2 tygodni temu

    Warszawa, Mazovia, Polska Perrigo Pełny etat

    Description Overview Within the Consumer Self-Care International business unit (main focus on Europe), lead the growing and evolving Regulatory Affairs Operations team responsible for centralised Regulatory systems & processes and Regulatory data management & compliance. Scope of the Role The main objectives of the job are To be the main...

  • Senior Manager Regulatory Operations

    2 tygodni temu

    Warszawa, Mazovia, Polska Perrigo Pełny etat

    Perrigo Company is committed to improving lives by offering Affordable Self-care products that consumers trust wherever they are sold. Join us in this mission.Overview of the RoleAs part of the Consumer Self-Care International business unit, with a primary focus on Europe, you will lead the Regulatory Affairs Operations team. This team is responsible for...

  • Regulatory Affairs Manager CEE

    2 tygodni temu

    Warszawa, Mazovia, Polska Galderma Pełny etat

    DescriptionKey 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...

  • Technical Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Leap29 Pełny etat

    Job Title: Technical Project Manager - EPC (Renewable Energy) - Eastern EuropeIntroduction: Leap29 is currently assisting a key client in Eastern Europe to fill the position of Technical Project Manager. Our client, a leading player in the renewable energy industry, is seeking a talented individual to contribute to their dynamic team, driving their wind and...

  • Senior Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska eConsulting Pełny etat

    What is the project about?Our client, a well-known bank, is undergoing a crucial Flexcube upgrade project as part of their Core Banking Transformation program. This initiative comprises four major streams, each interdependent: Flexcube Transformation Non-production platform delivery Pan-Baltic integration platform Infrastructure and Network strategy...

  • Research Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska RetinAI Medical Pełny etat

    Ikerian AG (formely RetinAI Medical) is a fast-growing medical device software company headquartered in Bern, Switzerland. Our mission is to enable the right decisions sooner in healthcare, through transformative AI & data management solutions for disease screening and monitoring. Join our diverse team of entrepreneurs, developers, researchers, and...

  • IT Senior Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska POL Fortrea Poland Sp z o.o. Pełny etat

    As a prominent global contract research organization (CRO) with a dedication to scientific rigor and extensive experience in clinical development, Fortrea offers pharmaceutical, biotechnology, and medical device clients a variety of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a workforce of over...

  • Regulatory Clinical Trial Application Submission Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etat

    Manpower (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...