Senior Regulatory Affairs Expert İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
DSM – Bright Science. Brighter Living.™
Royal DSM is a global, purpose-led, science-based company active in Nutrition, Health and Sustainable Living. DSM’s purpose is to create brighter lives for all. DSM addresses with its products and solutions some of the world’s biggest challenges while simultaneously creating economic, environmental and societal value for all its stakeholders – customers, employees, shareholders, and society at large. DSM delivers innovative solutions for human nutrition, animal nutrition, personal care and aroma, medical devices, green products and applications, and new mobility and connectivity. DSM and its associated companies deliver annual net sales of about €10 billion with approximately 23,000 employees. The company was founded in 1902 and is listed on Euronext Amsterdam.
Global use of and the market approval for Food, Feed, Human and Animal Health and Personal Care products is highly regulated, the requirements are very diverse between regions. To ensure that the DSM products are following these complex regulations, Regulatory Affairs defines the internal requirements for new products to ensure efficient market clearances. This also requires an ability to manage cultural differences.
Regulatory Affairs further provides guidance for existing products in the context of production improvements, product changes or line extensions and new applications. This also includes the final responsibility for the assurance of the safety, the availability and the safe use of microbiological strains.
Regulatory Affairs is the interface between the external authorities and the internal R&D, Safety and Marketing Units. In this specific area of expertise Regulatory Affairs represents DSM externally. In the interaction with the DSM customers RA provides a high standard consultation in areas of expertise and as such adds value to the business process.
The Position
Within DSM we are currently looking for a Senior Regulatory Affairs Expert located in Turkey or Egypt.
Your responsibilities include:
- To cooperate as a RA team member in the joint efforts for the development of the global product approval strategy in a timely and accurate manner
- Investigating new regulatory areas and contributes to RA strategies in these fields
- Preparing Dossiers, product related documentations and necessary registration certificates for Product approvals based on the global regulatory affairs strategies or adaptation and submission of the dossier to the local authority and follow up on the approval process
- Contributing to secure regulatory compliance also covering the safety of the products
- By exception being active in global or regional representation, networking and shaping activities
- Providing input on changing regulatory environments
- Contributing to the development of DSM opinions in Reg. Affairs
- Prepares and issues regulatory statements
The Challenge
Regulatory Affairs is a cross functional activity with a high level of complexity based on the dynamics of global markets, different and changing global regulatory environments, public awareness and science focus of authorities and customers. Internally Regulatory Affairs has to integrate input from Marketing, Safety Health and Environment, Toxicology, R&D and Quality Management on a global level.
To support the sales organization Regulatory Affairs has to provide easy understandable correct product information with regard to regulatory compliance and approval status of the portfolio.
Provide guidance towards external customers concerning the interpretation of regulations and implication on their business.
Facing increasing requirements for the approval process Regulatory Affairs has to develop efficient and effective strategies to achieve approval for the portfolio.
- Master or Bachelor’s degree, in natural sciences or life sciences
- Recognized expert in Regulatory Affairs; experience in food legislation in the Middle East is a plus
- Interdisciplinary knowledge in the following areas: Analytics, Chemistry and production process, Biology and Toxicology (basics and solid)
- Customer orientation with consultative skills – strong aptitude for proactively identifying needs and defining solutions
- Strongly self-motivated; solves business problems and works well with limited supervision
- Strong verbal and written communication skills
- Able to perform in a fast-paced work environment where constant re-prioritization is required
- Fluent in English, any other language is an asset
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