Regulatory Affairs Associate/Manager

6 dni temu

Warszawa, Polska Procter And Gamble Polska Sp. z o.o. Pełny etat

Regulatory Affairs Associate/Manager


47_R000119034

Obowiązki

  • 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 the local point of view regarding all initiatives (e.g. registrations of new products) and maintenance activities (e.g. variations) and ensure submissions are done in time.
  • Accurate maintenance of the Corporate Database on product information and any external database (if applicable).
  • Review, approve and ensure full compliance of artworks.
  • Revision and clearance – via Corporate system – of advertising materials to ensure full compliance with local requirements.
  • Ensure compliance of the local P&G Health product portfolio to applicable regulations, guidelines and internal standards. .
  • Regulatory Intelligence: advise the broader organization – both local and global stakeholders.
  • Strong interaction with the commercial organization. To advise organization of potential regulatory risks and recommend actions.
  • Interaction with local Boards of Health (BoHs) and Trade Associations (Tas): first point of contact, including positive relationship and present the interests of the organization, gain relevant information and help craft change.
  • Prepare and submit all Pricing applications.
  • Close collaboration with Quality Assurance (QA) by: co-operating during internal audits, leading/attending inspections and implementing CAPA plans, ensuring the Corporate Change Control System is kept up to date.

Wymagania

  • Minimum a MSc degree or equivalent experience in life- or natural science (e.g. medical/veterinary doctor, pharmacy, biology, chemistry, bioengineer etc.).
  • Proficiency in Polish and English.
  • Proven track record to rapidly acquire knowledge and understanding of therapeutic categories, analyze scientific and clinical data, translate information into business relevant language and messaging.
  • Strong communication skills.
  • Outstanding collaboration and teamwork sills.
  • Comfortable in working in a matrix organization with multiple partners, stakeholders and customers.
  • Demonstrated ability to handle competing priorities effectively.

Oferujemy

  • Competitive starting salary and benefits program (private health care, life insurance, PG stock options, saving plans, lunch subsidy, sport cards, in-office fitness center, company car and parking).
  • Career development in a multinational company with a friendly team and high standards.
  • Regular salary increases and possible promotions - all in line with your results and performance.
  • P&G Vibrant Living programs.
  • Regular salary increases and possible promotions - all in line with your results and performance.

Źródło: P&G/Praca

Aplikuj

 

  • Regulatory Affairs Associate

    1 miesiąc temu

    Warszawa, Polska Parexel Pełny etat

    When 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...

  • Regulatory Affairs Professional

    1 miesiąc temu

    Warszawa, Mazovia, Polska Procter And Gamble Polska Sp. z o.o. Pełny etat

    Job 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 Professional with a Focus on Product Compliance

    1 tydzień temu

    Warszawa, Mazovia, Polska Procter And Gamble Polska Sp. z o.o. Pełny etat

    Are 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...

  • Senior Regulatory Affairs Manager

    4 miesięcy temu

    Warszawa, Polska Parexel Pełny etat

    When 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...

  • Principal Regulatory Affairs Consultant

    4 miesięcy temu

    Warszawa, Polska Parexel Pełny etat

    When 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...

  • Regulatory Affairs Specialist

    3 tygodni temu

    Warszawa, Mazovia, Polska Procter And Gamble Polska Sp. z o.o. Pełny etat

    Job 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 for Central Europe Senior Manager

    7 miesięcy temu

    Warszawa, Polska 475 Avon Cosmetics Limited (UK) Pełny etat

    You’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...

  • Principal Regulatory Affairs Consultant

    2 miesięcy temu

    Warszawa, Polska Parexel Pełny etat

    When 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 Project Lead

    2 miesięcy temu

    Warszawa, Polska Parexel Pełny etat

    When 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 Consultant – MAAs Global Acceleration Initiative

    3 miesięcy temu

    Warszawa, Polska Parexel Pełny etat

    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...

  • Senior Regulatory Specialist, CTA/IND

    7 miesięcy temu

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

    We 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 Business Development Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Grafton Recruitment Sp. z o.o. Pełny etat

    As a Senior Business Development Manager at Grafton Recruitment Sp. z o.o., you will be responsible for expanding our business in the healthcare sector.The estimated salary for this position is approximately 85,000 - 110,000 PLN per annum, depending on experience and qualifications.Job DescriptionWe are seeking a highly motivated and experienced Key Account...

  • Sales & Recruitment Senior Consultant / Associate Manager (Consumer Goods)

    6 dni temu

    Warszawa, mazowieckie, mazowieckie, Polska Goldman Recruitment Pełny etat

    Sales & Recruitment Senior Consultant / Associate Manager (Consumer Goods)Miejsce pracy: WarszawaRekrutujemy dlaDo naszego zespołu Sales & Marketing, szukamy kandydata na stanowisko Sales & Recruitment Senior Consultant / Associate Manager (Consumer Goods).Twój zakres obowiązkówaktywne budowanie sieci kontaktów i relacji biznesowych w branży Consumer...

  • Country Clinical Lead

    2 dni temu

    Warszawa, Polska HAYS Pełny etat

    Country Clinical LeadWarszawaNR REF.: 1190881Key Responsibilities:• Act as the local representative of the company authorized by the Managing Director, to oversee legal affairs, human resource management, regulatory intelligence and compliance, financial management, vendor identification and contracting, and business development activities within the...

  • Customer Success Representative

    3 tygodni temu

    Warszawa, Mazovia, Polska Grafton Recruitment Sp. z o.o. Pełny etat

    Company OverviewGrafton Recruitment Sp. z o.o. is a leading recruitment agency in the healthcare sector, seeking a skilled Key Account Manager to join their team.About the RoleWe are offering a challenging and rewarding opportunity for a seasoned professional with experience in FMCG and pharmacy areas. The successful candidate will be responsible for...

  • Medical Writer

    4 tygodni temu

    Warszawa, Polska ITP S.A Pełny etat

    Medical WriterYour responsibilities Assist in the preparation of medical and scientific documents, including manuscripts, clinical study reports, abstracts, posters, and presentations. Conduct literature searches and analyze scientific data to support content development. ...

  • SAP Security ETD Product Manager

    1 miesiąc temu

    Jutrzenki , Warszawa, Polska Bosch Polska Pełny etat

    Bosch Polska, a leading innovator in high-quality technologies and services, seeks an experienced SAP Security ETD Product Manager to join its team. The successful candidate will be responsible for developing a clear vision and strategy for the SAP ETD product/solution, aligned with organizational goals and security policies.With a strong focus on...

  • Quality Assurance Expert

    11 godzin temu

    Warszawa, Polska Michael Page Pełny etat

    About Our OrganizationWe are a global leader in innovative solutions and advanced technologies across the medical and life sciences.Job OverviewDevelop and implement quality standards, promoting a culture of excellence throughout our teams.Lead the improvement of our Quality Management System (QMS) in line with ISO 9001:2015 and ISO 13485:2016...

  • Key Account Manager

    3 dni temu

    Warszawa, Polska Farco Pharma GmbH Pełny etat

    O nas: FARCO-Pharma to wiodąca, międzynarodowa firma działająca w obszarze urologii i neuro-urologii. Z siedzibą w Niemczech rozwijamy, produkujemy i dystrybuujemy wysokiej jakości leki oraz wyroby medyczne, które zwiększają bezpieczeństwo procedur medycznych i trwale poprawiają jakość życia pacjentów. Nasze innowacyjne rozwiązania są...

  • Quality Specialist

    17 godzin temu

    Warszawa, mazowieckie, Polska Michael Page Pełny etat

    About Our ClientA global well known organisation in innovative solutions and advanced technologies across the medical and life sciences.Job DescriptionProvide training on quality standards and foster a culture of quality awareness across teams.Manage and improve the QMS in line with ISO 9001:2015, ISO 13485:2016, and local regulations.Organize and conduct...