Regulatory Affairs Project Director
3 tygodni temu
The Regulatory Affairs Project Director (RAPD) is an experienced regulatory specialist with strong project management capabilities who takes on critical leadership roles for particularly complex and high priority global regulatory projects and / or major submissions. Typical capabilities for the RAPD are; to develop and maintain successful strategic and collaborative relationships, to proactively influence and negotiate across local and global teams and to independently resolve issues and drive accelerated delivery plans.
The RAPD provides regulatory expertise and guidance on procedural and documentation requirements to all stakeholders and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives globally. The RAPD may also lead continuous improvement, transformation and critical business development projects, driving initiatives for efficiency and productivity across the business.
Your responsibilities could include, but are not limited to:
Drive and lead delivery focused teams, e.g., GRET (Global Regulatory Execution Team), RSDT (Regulatory Submission Delivery Team). Assume overall accountability for the planning, forecasting and reporting, utilising refined project and stakeholder management skills, ensuring optimised delivery of regulatory activities to time and quality. Be a core member of strategy teams, e.g. GRST (Global Regulatory Strategy Team) and RSST (Regulatory Submission Strategy Team), successfully collaborating with key stakeholders, challenging and contributing to ensure optimised delivery of regulatory strategy plans from Candidate Drug (CD) nomination through to submissions and approval to achieve critical milestones and scorecard goals. Ensure all compliance activities for the project/product are completed and maintained. Identify regulatory risks, opportunities and proactively develop mitigation strategies for operational regulatory activities, e.g. planned submissions, (with input from all team members). Facilitate stakeholder management and communication within Regulatory, cross functionally and across collaborations.As a senior member of the RAM community, the RAPD will:
Be a recognised expert in the current regulatory environment. Understand the regulatory framework, including regional trends for various types of applications, procedures and documents, in both small and large molecules with a particular focus on planning, delivery and project management. Be a recognized expert in the AZ Regulatory Operating Model and AZ Drug Development Process Be a visible, approachable leader and role model for the whole RAM community. Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of key regulatory activities, e.g. major submissions throughout the product’s life cycle from a global and/or regional perspective. May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies. Be a role model for AZ Values & Behaviours: personally driven to improve standards across the business, drive and lead continuous improvement and knowledge sharing of best practice through coaching and mentoring across the RAM community.Essential
University degree in science or a related discipline. Extensive regulatory experience within the biopharmaceutical industry, or combined with experience at a health authority Knowledge of regulatory procedures and legislation for drug development, throughout the product lifecycle Managed first wave Marketing Application/Line Extension and/or LCM submissions, as a Submission Delivery Team Lead (SDTL). Managed complex regulatory deliverables across projects/products. Thorough knowledge of drug development. Proven successful leadership and strong project management experience and skills. Strong influencing, stakeholder management and negotiating skills. Proficiency with common project management tools and methodology. Excellent written and verbal communication skills. Team facilitationDate Posted
23-Apr-2024Closing Date
12-May-2024-
Regulatory Affairs Manager
2 tygodni temu
Warsaw, Polska Innovaderm Research Pełny etatThe Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm’s standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction. Responsibilities include providing leadership on regulatory activities...
-
Regulatory Affairs Manager
3 tygodni temu
Warsaw, Polska Michael Page Pełny etatManaging all regulatory processes for our brand: Rx, OTC, food supplements, incl. management of product registration documents (procedures NP, MRP, DCP)coordination of all regulatory submissions and commitments, to obtain the approval decisionsClose cooperation with medical team to ensure an optimal regulatory knowledge, requirement and proceduresSubstantive...
-
Regulatory Affairs Specialist Medical Devices
1 miesiąc temu
Warsaw, Polska Colgate-Palmolive Company Pełny etatNo Relocation Assistance Offered # 158344 - Warsaw, Mazovia, PolandWho We Are Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and...
-
Senior Manager Regulatory Operations
2 tygodni temu
Warsaw, Polska Perrigo Pełny etatDescription 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...
-
Regulatory Affairs Manager
4 tygodni temu
Warsaw, Polska IQVIA Pełny etatThe Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.• Provide...
-
Regulatory Affairs Associate
4 tygodni temu
Warsaw, Polska Zoetis Pełny etatRegulatory Affairs Associate - Contract for 1 year Position purpose: The Regulatory Affairs Associate will be part of a small team in Poland acting as a bridge between our Research and Development (R&D) and International Operations (Commercial) divisions, ensuring that registration dossiers meet market-specific needs and are delivered according...
-
Global Development Medical Director
3 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatLocation (on-site): Barcelona or Warsaw preferred. As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader (GCPL) and Global Clinical Head (GCH) with the design, implementation, conduct and interpretation of Phase 2b to Phase IV studies to support respiratory product development...
-
Regulatory Affairs
3 tygodni temu
Warsaw, Polska People Sp. z o.o. Pełny etatDla Naszego Klienta – międzynarodowej firmy z branży farmaceutycznej poszukujemy osoby na stanowisko:Regulatory Affairs / Pharmacovigilance SpecialistLokalizacja: Warszawa Śródmieście (praca hybrydowa)Zakres obowiązków:Działania związane z utrzymaniem pozwoleń na dopuszczenie do obrotu (MA), odpowiedziami na pytania i zobowiązania regulacyjne,...
-
Medical Affairs Manager Poland
4 tygodni temu
Warsaw, Polska Galderma Pełny etatDescription Key Responsibilities Provide expert medical advice and education to internal and external stakeholders on Galderma's products, clinical trials, and new developments. Develop and implement local medical affairs plans aligned with global strategy. Lead the training of internal staff on product knowledge and disease awareness. ...
-
Senior Global Development Scientist Director
2 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatJob Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes...
-
Evidence Platforms Associate Director
3 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatBioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AZ therapies and support our internal stakeholders with medical insight and expertise. BPM provides medical leadership with market participation and connectivity while also impacting the...
-
Study Start Up and Regulatory Affairs Specialist
3 tygodni temu
Warsaw, Polska Ergomed Pełny etatJob Description We are looking for someone who can speak German Provides Study Start-Up Specialist activities in support of assigned projects including regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and review in preparation of site initiation and activation. Provides...
-
Study Start Up and Regulatory Affairs Specialist
3 tygodni temu
Warsaw, Polska Ergomed Pełny etatJob DescriptionWe are looking for someone who can speak GermanProvides Study Start-Up Specialist activities in support of assigned projects including regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and review in preparation of site initiation and activation. Provides leadership to junior...
-
Country Director, Poland
2 tygodni temu
Warsaw, Polska International Rescue Committee Pełny etatRequisition ID: req51610 Job Title: Country Director, Poland Sector: Emergency Response Employment Category: Fixed Term Employment Type: Full-Time Open to Expatriates: No Location: Warsaw, Poland Work Arrangement: In-person Job Description In Ukraine, months of escalating Russian hostility culminated in a concerted invasion...
-
Warsaw, Polska IQVIA Pełny etatPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
-
Associate Director, Statistical Programming
3 tygodni temu
Warsaw, Polska AstraZeneca Pełny etatAssociate Director, Statistical Programming, Late Stage Respiratory & Immunology Location : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week Reporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology) Would you like to lead a Programming team,...
-
Macro External Regulatory Reporting
4 tygodni temu
Warsaw, Polska JPMorgan Chase & Co. Pełny etatBecome an integral part of our Macro External Reporting team! Each day will be unique – bring a positive attitude, inquisitive spirit and get ready to roll up your sleeves. This position is an essential part of the team and you will be joining a dynamic and growing team in a fast paced and challenging area. The external reporting function handles the...
-
Regulatory and Start Up Specialist 2
1 tydzień temu
Warsaw, Polska IQVIA Pełny etatJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions....
-
Project Manager, Early phase
7 dni temu
Warsaw, Polska Innovaderm Research Pełny etatProjects Managers are crucial to the success of Clinical Trials managed by Innovaderm. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected.Great project managers go further than creating project plans and following up on tasks. They show leadership to...
-
Macro External Regulatory Reporting
3 tygodni temu
Warsaw, Polska J.P. Morgan Pełny etatJob Description Become an integral part of our Macro External Reporting team! Each day will be unique – bring a positive attitude, inquisitive spirit and get ready to roll up your sleeves. This position is an essential part of the team and you will be joining a dynamic and growing team in a fast paced and challenging area. The external reporting function...
