Senior Regulatory Affairs Consultant – MAAs Global Acceleration Initiative
3 miesięcy temu
When our values align, there's no limit to what we can achieve.
We are seeking experienced Regulatory Affairs professionals to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets. This is an exciting opportunity to play a crucial role in accelerating time to filing and approval in Global Country Initiative (GCI), emerging markets, and non-EU markets.
Our global regulatory teams are well supported to prioritise our major markets filings and are targeting high quality simultaneous filings with Stringent Regulatory Authorities (SRAs)as well as rest of world markets. Our ambition is to accelerate the time for submission, approvals and accessing markets, and this role’s mission will be to help realise this ambition.
Key Responsibilities:
Develop and implement global regulatory strategies for simultaneous marketing authorisation submissions
Identify risks and mitigations to protect business interests and maintain timelines
Lead detailed preparation of regulatory plans for individual country filings
Lead global filing teams in generating country-specific datasets and updating core documentation
Lead adaptation of core dossier contents for country submissions
Coordinate filing teams for RTQ generation, provide strategic guidance to the global filing teams to address the regulators question and guide the team to prepare high quality responses.
Set up global filing team meetings, draft responses, coordinate reviews and approvals.
Suggest and coordinate innovative regulatory procedures to increase acceleration opportunities
Work closely with the local and regional regulatory leads on all aspects of marketing review and approvals.
Manage routine MA maintenance activities as required
Qualifications and Experience:
University degree in a life science industry
8-15 years of relevant regulatory affairs experience
Extensive experience in preparing global filing plans for markets worldwide, and awareness of regulatory frameworks in all major markets globally
Strong leadership skills and motivated, to support senior filing teams through marketing applications, overarching CMC, Clinical and Nonclinical.
Familiarity with CPPs and timing for filings in various markets
Proficiency in Veeva Vault and other regulatory systems
Excellent communication and organizational skills
Experience working within a regulatory matrix team in the pharmaceutical industry
Fluent in English, written and spoken
-
Regulatory Affairs Project Lead
2 miesięcy temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. We are currently looking for a Senior Regulatory Affairs Consultant (Project Lead) ! As a Senior Consultant you will be responsible for leading internal projects on behalf of Parexel Clients. A Senior Consultant provides a broad range of consulting services and works within project...
-
Senior Regulatory Affairs Manager
4 miesięcy temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies...
-
Regulatory Affairs Associate
1 miesiąc temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. Are you passionate about regulatory affairs in the life science industry? Do you thrive in a dynamic team environment and enjoy managing complex projects? Parexel is seeking a talented Regulatory Affairs Associate to join our growing team! As a Regulatory Affairs Associate at...
-
Principal Regulatory Affairs Consultant
4 miesięcy temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong...
-
Principal Regulatory Affairs Consultant
2 miesięcy temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines. The ideal candidate will...
-
Regulatory Affairs for Central Europe Senior Manager
7 miesięcy temu
Warszawa, Polska 475 Avon Cosmetics Limited (UK) Pełny etatYou’ve picked a great time to join Avon. We’re the company that puts purpose, people and relationships at the heart of everything we do. The company that’s 135 years young and only just getting started. As part of the Natura &Co family, we’re committed to being the best beauty company for the world by generating a positive environmental, economic...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Procter And Gamble Polska Sp. z o.o. Pełny etatJob DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Procter and Gamble Polska Sp. z o.o.About the RoleThe successful candidate will be responsible for managing all regulatory activities needed to acquire Marketing Authorizations (MAs) and other authorizations for medical and non-medical products in Poland.This...
-
Regulatory Affairs Professional
1 miesiąc temu
Warszawa, Mazovia, Polska Procter And Gamble Polska Sp. z o.o. Pełny etatJob Title: Regulatory Affairs Associate/ManagerA competitive salary and benefits package is offered to the successful candidate.Company Overview:We are a leading multinational consumer goods company with a presence in Poland. Our team is dedicated to ensuring compliance with regulatory requirements and providing exceptional customer service.Job...
-
Regulatory Affairs Associate/Manager
6 dni temu
Warszawa, Polska Procter And Gamble Polska Sp. z o.o. Pełny etatRegulatory Affairs Associate/Manager47_R000119034Obowiązki Manage all regulatory activities needed to acquire Marketing Authorizations (MAs) and other authorizations for all medical and non-medical products (e.g., medical devices, food supplements, cosmetics) in Poland.Regulatory strategy: contribute to the development of the strategy by sharing...
-
Warszawa, Mazovia, Polska Procter And Gamble Polska Sp. z o.o. Pełny etatAre you an ambitious professional looking for a challenging role in regulatory affairs? Do you have a strong background in life or natural sciences and excellent communication skills? We are seeking a highly motivated Regulatory Affairs Associate/Manager to join our team at Procter And Gamble Polska Sp. z o.o.About the RoleWe offer a competitive salary of...
-
Global Compensation Consultant
2 tygodni temu
Warszawa, Mazovia, Polska Sonova Warsaw Service Center Sp. z o.o. Pełny etatAbout the Role">This is a temporary 5-month position within our Corporate Total Reward CoE team. As Global Compensation Consultant, you will play a key role in supporting the implementation and maintenance of compensation and benefits related processes, projects, policies, and practice to ensure alignment with global guidance and market best practices.Job...
-
Senior Regulatory Specialist, CTA/IND
7 miesięcy temu
Warszawa, 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 Embedded Software Engineer for GPU Acceleration
1 tydzień temu
Centrum, Warszawa, Polska Google Pełny etatAbout the RoleAs a Senior Embedded Software Engineer on Google's Devices & Services team, you will play a critical role in developing cutting-edge technologies that accelerate user experiences. Our engineers push the boundaries of what is possible with innovative solutions, and we are looking for talented individuals to join our team.We are seeking an...
-
Consultant
1 miesiąc temu
Warszawa, mazowieckie, Polska United PRKetchum Pełny etatUnited PR z siedzibą w Warszawie to polska firma doradcza, która łączy komunikację ze strategicznym doradztwem biznesowym. W ciągu ostatnich lat do profesjonalnych usług public relations dobudowaliśmy unikalne kompetencje w obszarach corporate affairs, governmental affairs i public affairs. United PR została założona 28 lat temu jako jedna z...
-
Senior Software Architect
4 tygodni temu
Warszawa, Mazovia, Polska Ringier Axel Springer Tech Pełny etatWe are looking for a skilled Senior Fullstack Engineer to join our team at Ringier Axel Springer Tech. This is a unique opportunity to work on cutting-edge, cloud-native solutions and transform how media industry clients operate.As a Senior Fullstack Developer, you will be part of an innovative international initiative focused on leveraging data and...
-
Global Business Consultant with French Proficiency
3 tygodni temu
Warszawa, Mazovia, Polska HRK S.A. Pełny etatWe are seeking a highly skilled Global Business Consultant to join our team in Warsaw, Poland. This is an exciting opportunity for a talented individual to leverage their expertise in contract law and business operations to drive growth and success.Company OverviewAs a global business consulting advisory provider, we help organizations navigate complex...
-
Warszawa, Mazovia, Polska Sonova Warsaw Service Center Sp. z o.o. Pełny etatWe are seeking an experienced Lead SAP Business Systems Consultant to join our team at Sonova Warsaw Service Center Sp. z o.o.About the RoleThis position is part of our global SAP CC team, working closely with colleagues in Switzerland, North America, and Asia. As a Lead SAP Business Systems Consultant, you will have the opportunity to shape our...
-
Global SAP Business Systems Consultant eWM Lead
3 tygodni temu
Warszawa, Mazovia, Polska Sonova Warsaw Service Center Sp. z o.o. Pełny etatAt Sonova Warsaw Service Center Sp. z o.o., we are seeking a highly skilled Senior SAP Business Systems Consultant to join our team.We offer a new challenge, with interesting tasks and much more – including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, attractive...
-
Senior Cloud Consultant
6 miesięcy temu
Warszawa, Polska dbschenker Pełny etatYour tasks Become part of a global team within the Global Platform Services located all over the world Develop and deliver Solution Designs for cloud and edge infrastructure components worldwide in an agile environment Support the transition/implementation of global application environments to the Schenker multi-hybrid-cloud Develop and implement...
-
Warszawa, Mazovia, Polska emagine Polska Pełny etatJob Title: Senior Dynamics 365 Implementation ConsultantLocation: Poland (hybrid work)Estimated Salary: €60,000 - €80,000 per yearIndustry: BankingContract: B2BAbout the Role:We are seeking a highly skilled and experienced Senior Dynamics 365 Implementation Consultant to join our team at emagine Polska. As a key member of our implementation team, you...