Group Regulatory Affairs Manager & Quality Management for Consumer Goods 100%

View: 124

Update day: 08-04-2024

Location: Oftringen Aargau AG

Category: Pharmaceutical / Chemical / Biotech Pharmacist / Pharmaceutical representatives

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Job content

Establish and maintain strategy to ensure regulatory compliance of new as well as already marketed food additive, pharmaceutical and cosmetic raw materials
Coordinate Regulatory Affairs registrations and product notifications
Prepare regulatory dossiers (e.g. DMF), liaise and follow up with regulatory authorities
Provide regulatory, quality and food safety intelligence and guidance to interdisciplinary teams (e.g. HACCP, ICHQ7 etc.)
Establish and maintain Corporate Directives, Standards, Procedures in the business area
Assist and support regional Regulatory, Quality and Food Safety experts
support of manufacturing plants in inspection readiness and audits
Participate in Association work & Committee meetings
Compliance training of employees

Life science degree (Master or PhD) such as chemistry, food technology or pharmaceutical
At least 5 years of work experience in the combined field of regulatory affairs and related quality management of food & pharma
Intensive knowledge of the international framework of food and pharmaceutical raw materials in terms of regulatory affairs and related Quality Management needs
Experience in association work and communication with authorities
Distinct solution-oriented way of working
Fluent in English; preferably also in German and French
Experience in working in a matrix structure is a plus
Readiness to travel about 20%.

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