Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in life sciences and materials sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders simultaneously.
Job Title : Regulatory Affairs Manager
Domain : Legal & Intellectual Property
Location : India, Gurgaon
Job ID: NUTR03597
The Challenge
Purpose of the position :Responsible for the product approval and maintenance of compliance in the different markets in South Asia for DNP’s HNH (Human Nutrition and Health) as well as DFS’s business groups as deemed necessary. Advices/recommends to Marketing and Sales, Product Management, DSCM, Purchasing in all regulatory and quality related topics/issues Support of marketing and sales in customer contacts to RA and QM /QC related topics including alignment of customer quality agreements and queries.Representation of DSM in industry associations working groups and supporting the local production sites in contact with local authorities.Job Context :Globally the use of and the market approval for Food, Supplement and Pharma ingredients is highly regulated and the requirements are very diverse between regions. To ensure that the DSM products are in compliance with these complex regulations, Regulatory Affairs /Quality Management advices
/ defines the internal requirements for new products to ensure efficient market clearances and compliance. This encompasses but is not limited to stability testing, heavy metal, residual solvent limits and other aspects in line with an in depth HACCP assessment.Regulatory Affairs/ Quality Management further provides guidance and support for existing products in the context of production improvements, product changes or line extensions, new applications and changing regulations and deviations. Regulatory Affairs / Quality Management is the interface between the external authorities and the internal R&D, Safety, Marketing Units and production sites. In this specific area of expertise Regulatory Affairs / Quality Management represents DSM externally. In the interaction with the DSM customers RA/QM provides a high standard consultation in areas of expertise and as such adds value to the business process.The Position
a) Key areas of accountability/responsibility
1. Leads the joint efforts for the development of the global product approval strategy in a timely and accurate manner.
2. Manage the Dossiers preparation for Product approval in collaboration with Product and Project Management based on the global regulatory affairs strategies of DNP and DFS. Adapt and submit the dossiers to the local authorities, follow up on the approval process
3. Work with Product Management and production sites to prepare and maintain in order to secure compliance of company / product documentation to law while Quality Assurance & Product Management are accountable for the correctness of product documentation.
4. Responsibility for local (e.g. IADSA; CII; FICCI; ILSI) representation, networking and shaping activities
5. Provide input on changing regulatory environments
6. Contributes to the development of DSM opinions in the area of Reg. Affairs and QM
7. Support Global QM for the product specific aspects in customer Quality agreements
8. Issue management related to product quality aspects e.g. impurity in close cooperation with all internal function (e.g QA, Marketing & Sales, DSCM, PM)
9. Representation of RQ/QM aspects in the local business meetings
i. Authorities1. Signing rights for statements on behalf of DSM (i.a. or i.V.; in specific cases ppa may be warranted)
ii. Projects/special assignments Complexity of the job :
• Regulatory Affairs / Quality Management 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 / Quality Management has to integrate input from Marketing and Sales (various industries and BU), SHE, Toxicology, R&D on a global level.
• To support the organization Regulatory Affairs/Quality management 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 / standards and implication on their business.
• Facing increasing requirements for the approval process Reg. Affairs Product Quality Management has to develop efficient, reliable and effective long term strategies to achieve approval for the portfolio.
Desired Profile :
Knowledge & Education :
• University degree in natural sciences life sciences
• Knowledge on regulations and standards for DNP HNH and DFS business
• Good language skills (English, local language where necessary, others appreciated).
• Team working skills
Required level of experience :
Recognized expert (in and out) and in depth experience in the reg. affairs / Quality Area (at least 4 years).Representing DSM in outside working groups as participant and in contact with officials from authorities and auditing units. Interdisciplinary knowledge in the areas Analytics, Chemistry and production process, Biology and Toxicology (basics and solid).
Close date: 2017-04-12
