Regional Director, Regulatory Affairs

7 dni temu


Kraków, Polska Pharmiweb Pełny etat
We are seeking a highly skilled and experienced Regional Regulatory Affairs Director (EMEA) to join our team. As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction. You will provide mentorship, leadership and direction to Managers and consulting employees, actively managing performance and development. You will succeed in this role thanks to your extensive Regulatory Affairs CMC experience, strong leadership, innovative thinking and ability to embrace changes.

Key Accountabilities:

  • Project Execution: Monitor the profitability of multiple projects, prepare project plans, and manage project budgets. Proactively avoid and resolve issues with revenue recognition. Provide guidance to project team members and act as a mentor to junior staff. Prioritize workloads and achieve project scope and objectives. Improve project efficiency, results, and team performance.
  • Staff Management: Actively manage performance, provide input on staff, support the management of their staff, facilitate staff development plans, and coordinate with project staffing to increase resource utilization and profitability. Provide leadership, coaching, mentoring, feedback, and role modeling to managers and extended staff. Communicate and champion organizational vision and values.
  • Consulting Activities and Relationship Management: Plan and deliver services and solutions that result in client satisfaction and build relationships. Identify opportunities for follow-on business, act as a trusted advisor to clients, and implement business solutions addressing specific client needs. Interact professionally at multiple levels, including senior management within client organizations.
  • Business Development: Actively prospect and leverage new business opportunities with clients and industry contacts. Present information about the company service offerings, deliver customized sales presentations, and actively engage in bid defense meetings. Generate new or repeat business due to personal name recognition or history of client satisfaction and/or relationship.


Skills, Knowledge, and Experience required for the role:

  • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree (MSc, PhD preferred)
  • Numerous years of experience in the life sciences or consulting industries with many years of experience managing people and projects
  • Extensive technical knowledge in CMC (biologics and/or vaccines would be a strong plus)
  • Experience in people management and development
  • Ability to influence others
  • Client-focused approach to work
  • Business acumen and analysis, including budgeting and forecasting
  • Excellent interpersonal and intercultural communication skills
  • Critical thinking and problem-solving skills
  • Operational leadership
  • Strategic business thinking


#LI-REMOTE

  • Kraków, Polska Maquet Cardiovascular LLC Pełny etat

    With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. ...


  • Kraków, Lesser Poland Michael Page Pełny etat

    About the Role: We are seeking a highly skilled and experienced Global HR Operations Director to lead our EMEA HR Operations & Payroll team. As a strategic leader, you will drive the vision for HR Operations & Payroll in the EMEA region, aligning your team's goals with our global HR strategy.Key Responsibilities:Strategic Leadership: Develop and implement a...


  • Kraków, Lesser Poland Huntsman Pełny etat

    Lead Transformation in European HR ServicesHuntsman Corporation's Regional HR Services team seeks a seasoned professional to drive the transformation of HR services across the EMEA region.About the RoleDetermine the strategic vision for HR Operations & Payroll in the EMEA, aligning your team's objectives with the broader global HR strategy.Take charge of the...


  • Kraków, Polska SwipeAPP Pełny etat

    Join Helprise – one of the fastest growing outsourcing and consultancy firms providing the best talent, know-how and solutions for the execution of business processes. Be part of building an ecosystem that gives unique value to our customers, partners, candidates and employees. We are your career advocates – offering extraordinary opportunities to grow...


  • Kraków, Polska Helprise Pełny etat

    Join Helprise – one of the fastest growing outsourcing and consultancy firms providing the best talent, know-how and solutions for the execution of business processes. Be part of building an ecosystem that gives unique value to our customers, partners, candidates and employees. We are your career advocates – offering extraordinary opportunities to grow...


  • Kraków, Polska Helprise Pełny etat

    Join Helprise – one of the fastest growing outsourcing and consultancy firms providing the best talent, know-how and solutions for the execution of business processes. Be part of building an ecosystem that gives unique value to our customers, partners, candidates and employees. We are your career advocates – offering extraordinary opportunities to grow...


  • Kraków, Polska Aon Pełny etat

    Senior Director - Commercial Risk Service Delivery Lead  Do you have Risk operations expertise? Are you ready for your next career move at Aon? This newly created role will be based in the Krakow, Poland service center, and will call on your Aon network and operations leadership experience across EMEA to create a cohesive service solution for...


  • Kraków, Lesser Poland Hyva Pełny etat

    About the Role">Hyva Group, a leading global provider of innovative and highly efficient transport solutions, is seeking an experienced Accounting Services Head for EMEA Region to drive financial excellence and efficiency across the region.">The ideal candidate will be responsible for overseeing accounting processes, ensuring timely and accurate reporting,...

  • ERP Director

    4 miesięcy temu


    Kraków, Polska Chabre IT Services Sp. z.o.o Pełny etat

    Working as an ERP Director, you will:Do the overall management of the ERP system adaptation and implementationUpdate the ERP Project Roadmap as work progresses and new regulatory requirements and business needs ariseEnsure the implementation of the ERP Project in accordance with the adopted assumptions, roadmap, scope, budget and schedule of the...


  • Kraków, Polska Shell Pełny etat

    , PolandJob Family Group:FinanceWorker Type:RegularPosting Start Date:Business unit:FinanceExperience Level: Experienced ProfessionalsJob Description: We are seeking a highly experienced, forward-thinker and senior-level Risk Manager to lead our regional EUAFME team for Global businesses within the Downstream Credit organization. This pivotal role involves...


  • Kraków, Lesser Poland Imperial Brands PLC Pełny etat

    Job Overview">We are seeking a highly experienced Compliance Operations Director to join our team at Imperial Brands PLC.The successful candidate will lead the development and implementation of effective internal control frameworks, ensuring robust assurance processes over financial and non-financial risks.This is an exciting opportunity for a skilled...

  • xLab Director

    4 miesięcy temu


    Kraków, Polska Chabre IT Services Sp. z.o.o Pełny etat

    Working as an xLab Director, you will:Comprehensive project management of the xLab system development and implementation (xLab = LIS type system)Management of the scope, budget and schedule of the ProjectUpdating the xLab Project Roadmap as work progresses and new regulatory requirements and business needs ariseEnsuring the implementation of the xLab Project...

  • Regional Medical Advisor

    1 miesiąc temu


    Kraków, Polska Novo Nordisk Pełny etat

       Czy potrafisz tłumaczyć i przekazywać złożone dane naukowe pracownikom służby zdrowia osobiście lub wirtualnie? Czy chcesz dołączyć do zespolu, ktory rozpoczyna globalny program ekspansji klinicznej i wkracza w nowe, ekscytujące obszary terapii, utrzymując jednocześnie naszą pozycję kluczowego lidera w leczeniu cukrzycy?W takim razie...


  • Kraków, Lesser Poland Chabre IT Services Sp. z.o.o Pełny etat

    Chabre IT Services Sp. z.o.o is a leading global professional IT services provider, building long-lasting relationships with Enterprises.We specialize in the delivery of tailor-made solutions, smart outsourcing, try&hire, and success fee services.We are looking for an experienced Project Director to lead our team in developing and implementing Laboratory...


  • Kraków, Polska Infotree Global Solutions Pełny etat

    DUTIES AND RESPONSIBILITIES:Manage current funded projects and ensure deliverables and milestones within the projects.Within Global Product Organization / Systems, Products Vehicle Architecture Group / Safety Architecture, Regulation Standards, and Public Fundings (GPO/SDV/VSR/RSF), you’ll be in charge of:• managing current funded project,• scouting...


  • Kraków, Lesser Poland State Street Pełny etat

    We are seeking a highly skilled and experienced Global Head of Liquidity Risk to join our team at State Street Global Advisors.As the Global Head of Liquidity Risk, you will be responsible for leading the oversight of liquidity risk across asset classes and investment styles for SSGA's investment products globally. This includes identifying key liquidity...

  • Portfolio Accounting Manager

    7 miesięcy temu


    Kraków, Polska HedgeServ Pełny etat

    HedgeServ is a leading global fund administrator with more than $450 billion in assets under administration across all investment vehicles including Hedge Funds, Private Equity Funds, UCITS, Hybrid Credit Managers, Funds of Funds and Managed Account Platforms. We optimize our clients’ experience using unique proprietary technology coupled with robotic...

  • Head of HR Operations

    4 miesięcy temu


    Kraków, Polska Michael Page Pełny etat

    Strategic Leadership: Drive the strategic vision for HR Operations & Payroll in the EMEA, aligning your team's goals with the broader global HR strategy. You will ensure that regional initiatives support our global objectives, contributing to the overall success of our HR function.Lead and Transform: Take charge of the European HR Operations & Payroll,...


  • Kraków, Polska Infotree Global Solutions Pełny etat

     At Infotree, meeting your career needs is a top priority. Client satisfaction is largely dependent on the resources we can provide, and we take pride in our delivery. We have a supportive team in place to give quality people a chance to grow and challenge themselves in their roles which has resulted in that we have placed many employees in positions that...


  • Kraków, Polska GOLDMAN RECRUITMENT Pełny etat

    For our client, an international production, multi-stream company, we are looking for a chief accountant responsible for a production plant in the Netherlands. The company's headquarters is in Krakow (remote work is possible).Responsibilities:support local statutory & compliance including VAT returns, payroll, tax returns and other local submissions,ensure...