Regulatory Affairs Lead
Regulatory Affairs Lead, Consumer Healthcare General Objectives Function: Leading the Regulatory Affairs group (total of 2 FTE) and in this sense support Consumer Healthcare (PCH) business unit for regulatory compliance in the Benelux and Nordic countries with applicable legal standards and legal obligations related to PCH medicinal products, dietary supplements, medical devices and cosmetics and to help achieve business goals. Where necessary support European/Global initiatives. Reports to: In this position you report to the Director of Regulatory Affairs, EMEA with a dotted line to the General Manager PCH Benelux/Nordics. Key Objectives: • Managing and evaluating various activities for getting new registrations and maintaining registrations and licenses in accordance with relevant legislation and aims to help achieve business goals. • Managing and evaluating coordination activities within the Benelux as Concerned Member State for various products. • Managing and evaluating activities arising out of and focused on meeting specific obligations and / or conditions related to registrations. • Managing and evaluating the Regulatory Affairs activities for getting and maintaining drug reimbursement (Denorex Rx). • Managing and evaluating activities arising out of and focused on meeting specific obligations and / or conditions related to notification of Food supplements, cosmetics and medical devices. • Provide where requested input on global/regional product development and commercialization strategies. • (Co)Responsible for Labeling approvals and creation of labeling text with marketing. • Review and approve all advertisements and promotional materials for medicines, nutritional supplements, cosmetics and medical devices • Follow up on legal requirements for advertisement and signal on trends (e.g. KOAGKAG) • Ensure legal compliance Advice, oversee and sign off on pharmacovigilance for medicinal products and be responsible for vigilance reporting for cosmetics, dietary supplements and devices as required under national law. • Scientific & medical input to advertisements to marketing departments •
