Junior Regulatory Affairs Manager Bij Merial

Categorie: Banen
Bedrijf: Mercuri Urval
Beschrijving: In deze functie ben je verantwoordelijk voor het verkrijgen van registraties voor diergeneesmiddelen en vaccins op de Nederlandse markt. Je rapporteert aan de RA Manager te Brussel. Jouw verantwoordelijkheden: Verzorgen van complete registratiedossiers voor de indiening van de aanvraag bij de registratieautoriteiten. Bewaken van de voortgang m.b.t. het verkrijgen van productregistraties. Adviseren over de Nederlandse wet- en regelgeving en productregistratie bij de lancering van nieuwe producten. Beheren van Standard Operating Procedures en zorgen dat deze worden nageleefd. Gevraagd wordt een communicatief vaardige kandidaat die minimaal 2 jaar ervaring heeft in een adviserende rol. Je bent geÃ¯nteresseerd in het (Europese) registratieproces. Je hebt een sterk probleemoplossend vermogen, bent nauwkeurig en hebt een hands-on mentaliteit. Jouw profiel: Een diploma in diergeneeskunde. Ervaring als dierenarts is een pluspunt. Goede beheersing van de Nederlandse en Engelse taal in woord en geschrift. Ervaring met Regulatory Affairs is een pre. Interesse in het (Europese) registratieproces. Je woont in (of bent bereid te verhuizen naar) de omgeving van Velserbroek. Geboden wordt een uitdagende functie bij een door innovatie gedreven onderneming die producten en oplossingen aanbiedt, die de gezondheid, het welzijn en de prestaties van dieren verhogen. MERIAL investeert grote bedragen in onderzoek en ontwikkeling. Sinds het ontstaan van het bedrijf heeft zij wereldwijd minimaal Ã©Ã©n nieuw product per jaar ontwikkeld en op de markt gebracht. Je komt te werken in een professioneel internationaal team en hebt contact met diverse afdelingen binnen het bedrijf en daarbuiten, o.a. Nederlandse en Europese autoriteiten. Standplaats is Velserbroek.
Locatie: Amersfoort
Educatie: WO
Uren: 32 - 40 uur
Datum: 2011-10-22

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Regulatory Affairs Manager / Sr. Regulatory Engineer
Beschrijving: Regulatory Affairs Manager / Sr. Regulatory Engineer Newell Rubbermaid is a global marketer of consumer and commercial products that touch the lives of people where they live, work and play. We are committed to building consumer and commercial Brands That MatterrTM while leveraging the benefits of being one company: shared expertise, operating efficiencies, and a culture of innovation. Our globally recognized brands include rotring, Sharpie, Paper Mate, DYMO, Waterman, Parker, Rolodex, IRWIN, LENOX, Rubbermaid, Graco, Calphalon, Goody, and teutonia . Rubbermaid Commercial Products (RCP) with its brands (Rubbermaid Commercial Products and Technical Concepts) is a division of Newell Rubbermaid Inc. It continues to develop innovative products and system solutions in the categories of food service, cleaning, safety, material handling, refuse, agriculture and automated restroom solutions including a vast array of skin care and air care products. Manufacturing is managed from four primary facilities: three in the US and one in Europe. RCP distribution is represented in North America, Latin America, Europe, Asia, Australia and the Middle East. The EMEA segment of RCP (Europe, Middle East, Africa) is experiencing rapid growth. This growth is the result of new and innovative products which are being introduced. The Corporation is in process of a restructuring initiative which will act to streamline business processes and provide an infrastructure for facilitating growth within the Region. We are currently building up a Center of Excellence in Hillegom , our EMEA manufacturing site. We are therefore recruiting for a Regulatory Affairs Manager / Sr. Regulatory Engineer SUMMARY Working closely with the Global R&D leadership team in Winchester, US. The Sr Regulatory Engineer is responsible for coordinating and actioning activities within regulatory affairs to ensure that all goods manufactured and services provided by the company meet the quality requirements of the company, regulatory and notified bodies. The Hilegom Center Of Excellence will be the European satellite R&D facility responsible for supporting growth initiatives in that region and around the world. RESPONSIBILITY Manage Regulatory Affairs area ensuring that objectives are implemented in line with the overall Quality/Corporate goals. Ensure compliance with local regulatory agencies and establish relationships with outside testing facilities as required. Provide updates regarding regulatory status and requirements, of Company products. Ensure customers receive regulatory and certification information seamlessly and in a timely manner. Compile device master records, technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to meet Company product(s) and regulatory requirements, and compliance to all approved licenses. Ensure staff understands and complies with the requirements of cGMP as applied to the Company's products. Provide related training and support to departments as needed. To review Change Control requests, deviation requests, quality system reports for adequacy and compliance with company and regulatory requirements. To participate in the investigation of failures and participate in continuous improvement initiatives. To provide regulatory support as required in the evaluation of customer complaints, ensuring complaint reports are closed out in accordance with the approved procedure. Participate in the development and maintenance of the Company's Quality System to meet the requirements of US FDA and all other applicable quality and regulatory standards. Qualifications Bachelors/Undergraduate Degree in quality or science (chemistry, biology, or medical technology). Five (5) years progressively responsible related experience in a Regulatory Affairs or Quality Assurance position.. Demonstrated experience in development and management of regulatory submissions and documentation, internal and external audit processes. Demonstrated expertise in cGMPs, FDA regulations, SOP development, understanding of Quality Assurance audit functions and Quality Control principles. Intermediate or advanced computer skills and a working knowledge of basic computer software. Microsoft Office preferred. Verbal and written communication skills, including the ability to conduct verbal presentations. Success working in a team environment. Travel may be required based on business need. What we can offer you! Newell Rubbermaid is a global company with a lot of opportunities, both internationally and locally and we encourage development on a professional and personal level. You will be working with some of the best known brands in the world and you will have colleagues who are highly motivated and competent. You can count on their support to achieve the goals you are aiming for. Are you interested? If so, please apply by uploading your resume via our online application tool by clicking on the application link on this site or by sending an email to antonio.cerina@newellco.com . For more information you may call John van Cassel at +31 252623294 and visist our websites at www.technicalconcepts.com and www.rubbermaid.eu . This is a job summary which includes essential job duties of the position. More specific information regarding duties may be provided upon request for particular locations and facilities. Newell Rubbermaid and its Business Units are Equal Opportunity Employers and comply with applicable employment laws. M/F/D/V are encouraged to apply.

Manager/associate Director Regulatory Affairs
Beschrijving: Manager/Associate Director Regulatory Affairs Pfizer Animal Health is a world leader in the discovery, development, manufacture and commercialization of products, including vaccines, medicines, diagnostics and genetic tests, to prevent and treat disease in livestock and companion animals. This business has operations in more than 60 countries, an extensive research and development network with major research centers on four continents and strong market positions across several geographic regions, including the United States, Europe, Africa and Middle East, Canada and Latin America, and Asia-Pacific. Summary of the job: This is an amazing chance to take your regulatory career to the next level! Would you like to work at the EU headquarters of one of the leading companies within animal health offering opportunities for personal growth? Do you like variation in your job? Are you dynamic, a team player and would you like to work with different nationalities? If yes, this might be your opportunity! You will provide strategic regulatory input and will be responsible for the implementation of regulatory strategies, you will obtain and maintain marketing authorizations for products and contribute in the development of new products for Europe, Middle East and Africa. Key Responsibilities/ Major Accountabilities: - you will drive the process for the planning, preparation, submission and the approval of new applications, variations, renewals and line extensions for products within your portfolio following CP/MRP/DCP, including: o Leading interactions with health authorities at the European level for specific regulatory applications o Developing and updating contingency plans for issues that affect registration and continued lifecycle management of the product o Making sure that the registered products are in compliance with current legislation o Coordinating and checking of product literature translations - you will contribute to the development of new medicines. You will participate in project teams. o Developing and executing the regulatory strategy for new medicines. o Being the regulatory expert on guidelines and procedures o Representing the regulatory viewpoint on teams and across multiple disciplines, including regulatory risk assessments and mitigations associated with proposed strategies.

Junior Product Group Manager Gezelschapsdieren Bij Merial
Beschrijving: In deze functie ben je mede verantwoordelijk voor de ontwikkeling en uitvoering van marketingplannen voor in-line producten of productgroep(en), waaronder Frontline; wereldwijd de nummer 1 in de bestrijding van vlooien en teken. Je rapporteert aan de Product Group Manager Gezelschapsdieren in Brussel. Jouw verantwoordelijkheden: InitiÃ«ren en coÃ¶rdineren van alle (pre-)launch activiteiten en productpositionering ter voorbereiding van succesvolle marktintroducties met het focus op Nederland. Monitoren van de verkoopactiviteiten overeenkomstig het marketingplan en zorgdragen voor de benodigde promotionele activiteiten/materialen om de verkoop te ondersteunen. Voorbereiden en samenstellen van het budget en promotionele activiteiten. Actief bijhouden en communiceren van ontwikkelingen in de markt. Gevraagd wordt een creatieve en communicatieve kandidaat zich verder wil ontwikkelen binnen de marketing van diergeneesmiddelen voor gezelschapsdieren. Je toont initiatief en bent een teamspeler die actief bijdraagt aan de marketingstrategie. Jouw profiel: Academisch werk- en denkniveau aangevuld met een marketingopleiding. Minimaal twee jaar relevante werkervaring het liefst in een dual market omgeving (business-to-consumer en business-to-business). Kennis van de diergeneesmiddelenmarkt is een pre. Goede beheersing van de Nederlandse en Engelse taal in woord en geschrift. Je woont in (of bent bereid te verhuizen naar) de omgeving van Velserbroek. Geboden wordt een uitdagende functie bij een door innovatie gedreven onderneming die producten en oplossingen aanbiedt, die de gezondheid, het welzijn en de prestaties van dieren verhogen. MERIAL investeert grote bedragen in onderzoek en ontwikkeling. Sinds het ontstaan van het bedrijf heeft zij wereldwijd minimaal Ã©Ã©n nieuw product per jaar ontwikkeld en op de markt gebracht. Je komt te werken in een professioneel en internationaal team. Standplaats is Velserbroek.

Junior Regulatory Affairs Specialist
Beschrijving: Orangina Schweppes International (OSI) is part of one of the largest soft drink producers in Europe, the Orangina Schweppes Group. The group is now part of the Japanese Suntory group which is a globally leading FMCG group with sales over â‚¬15 billion. The Orangina Schweppes Group is a major company in the beverages sector whose quality branded products are enjoyed around the world, with premium brands like Schweppes, Orangina, Dr Pepper, Snapple, Trina, Oasis and La Casera. The Orangina Schweppes Group has a workforce of over 2,000 employees, sales volumes of 1.3 billion litres and a turnover of almost â‚¬1 billion. OSI is the Intellectual Property owner of many of the brands of the Group and is responsible for its worldwide sales, in countries in which Orangina Schweppes Group does not have its own bottling operations. OSI is committed to providing equal employment opportunities and fostering an environment, which attracts and retains a diverse and talented workforce. To strengthen the R&D Department, we are currently searching for a Responsible for ensuring regulatory compliance of recipes & labels and supporting the two International Regulatory Affairs Specialists with technical and regulatory topics Evaluating and correcting artwork and creating Labelling Information Notes regarding (new) product launches and redesigns Ensuring registration, analysis and actively sharing of regulatory texts supplied by internal and external sources Working closely together with colleagues of R&D, Marketing and Commercial, Technical Managers and external relations Providing assistance in all required subjects related to trade associations Reporting to both International Regulatory Affairs Specialists. Responsible for ensuring regulatory compliance of recipes & labels and supporting the two International Regulatory Affairs Specialists with technical and regulatory topics Evaluating and correcting artwork and creating Labelling Information Notes regarding (new) product launches and redesigns Ensuring registration, analysis and actively sharing of regulatory texts supplied by internal and external sources Working closely together with colleagues of R&D, Marketing and Commercial, Technical Managers and external relations Providing assistance in all required subjects related to trade associations Reporting to both International Regulatory Affairs Specialists. If you are interested in this position, please contact Imke Maas, telephone: +31 (0)317-468686 of +31 (0)6-23573775, or email/send your written application to: info@dupp.nl / Den Uijl Ploeg & Partners, Gen. Foulkesweg 66, 6703 BW Wageningen, the Netherlands.

Junior Regulatory Affairs Specialist (first Step For Young Talent In Food Legislation)
Position Responsible for ensuring regulatory compliance of recipes & labels and supporting the two International Regulatory Affairs Specialists with technical and regulatory topics Evaluating and correcting artwork and creating Labe...