Our client is a leading health care company and is currently seeking an accomplished Senior Manager of Regulatory & Compliance to join the team. Here is an overview of the role:
1) Achieve and maintain compliance across all products distributed by company in any channel and in any retail environment in the USA e.g. Walgreens, QVC Shopping Channel
2) Be accountable to make any necessary submission to FDA or other regulatory bodies as needed in a timely manner and to provide the Central International Regulatory team with copies of any approvals or receipts in a timely manner, and copies of the actual submission as requested for commercial, regulatory or audit purposes
3) Deliver quality and regulatory advice to the local business to protect and enhance the brand for new product development whether own consumer brand or retail brand, and for the product lifecycle i.e. maintenance support
4) Set local KPIs for regulatory and compliance in market
5) Set up relationships with appropriate local suppliers to maintain regulatory compliance according to policy and standards
6) Carry out any due diligence as agreed and provide timely reports to senior management ongoing
7) Ensure that local and central company organization is kept fully aware of changes in the State and Federal Legal and Regulatory requirements e.g. prop 65 for nitrosamines
8) Collaborate with relevant central businesses or departments across company to deliver an impact analysis of such changes
9) Ensure alignment of understanding and views between USA Regulatory and Compliance and EU Cosmetic Registration team, one voice approach
10) Be accountable to work with the International Registration Team Manager and the Director of Pharmaceuticals Medical Regulatory and Quality to deliver the necessary local submissions and registrations for Brand and Exclusive Brands in the agreed priorities
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