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Manager, Technical Services and International Registration
- Domestic and International Regulatory Strategy
- Industry leading company
About Our Client
Leader in health and wellness by introducing innovative health and wellness products and solutions to the marketplace.
The Manager ensures smooth, efficient and effective functioning of the International Registrations department by facilitating the registration and importation of products internationally; provides on-going support to Distributors and Regional Teams by providing product dossiers, tracking product/bulk changes, procuring and providing export documentation from various private and government institutions and initiates special requirements of foreign Ministries of Health, etc.
The Manager is responsible for ensuring the accuracy of technical and regulatory information pertaining to raw materials, ingredients and products while adapting to a rapidly evolving regulatory environment.
- Lead, develop and coach the Centralized International Registration Team to ensure that products are timely and appropriately registered internationally.
- Review and sign off on product dossiers before they are sent to Distributors and Ministries to ensure that correct and current information is submitted.
- Liaise with various government agencies like FDA, Depts. of Health, USDA, etc. for obtaining various export documentation like certificates of free sale, manufacturing site GMP certificate, animal/fish certs, etc.
- Provide timely response to queries from our International team / customers / distributors regarding product formulations, testing procedures, export documentation, and ingredient and product data.
- Liaise with various internal departments to obtain Certificates of Analysis, Stability Reports, Raw Material Specifications, Raw Material Certificates of Analysis, Nutritional Information, Test Methods, Clinical Studies, Structure Function Claims, etc. to support the registration process.
- Maintain an acceptable Service Level Agreement with internal customers and incorporate business process improvements and other measureable metrics to ensure expedience and lean efficiency in the Registration and Technical Services process.
- Resolves Distributor/Customer registration issues.
Reviews proposed alternate suppliers to ensure compliance with existing requirements and works with Product Development and Procurement teams to revise requirements as needed.
- Analyzes data to confirm ingredient/product claims for various end uses such as labels, advertising, websites, etc.
- Ensures that accurate technical information is provided to satisfy consumer, distributor and/or retail account inquiries.
- Interfaces with business units including Marketing, Product Development, R&D, Quality, Legal and Consumer Affairs.
The Successful Applicant
- Bachelor's Degree (BS or BA). Preferred fields of study include Regulatory Affairs, or Physical Life Sciences. Master's Degree a plus.
- Understanding of Code of Federal Regulations (CFRs), FDA & EU guidelines.
- Minimum five years of experience in a Regulatory environment or related industry, with at least three years of effective leadership experience in a management or supervisory role.
- Experience in the Nutritional Supplement field, FDA Regulations/Labeling Regulations or related industry a plus.
- Must have experience in MS Office applications (Excel, Word, Outlook), Adobe Acrobat, Mac and PC operating systems.
- Strong written and verbal communications and technical acumen
- Strong analytical reasoning, critical thinking and problem-solving skills; capable of exercising sound judgment when making decisions
- Highly motivated and displays a high level of initiative; ability to positively influence others and maintain an efficient team through coaching, delegating and developing capabilities of others
- Proven ability to work in a collaborative environment with a positive, hands-on approach which emphasizes team work and consensus building
- Comprehensive knowledge of laws and regulations in an FDA-regulated environment, preferably Knowledge or familiarity of food/supplement regulatory concepts
- Must be proficient with PC-based applications (Windows, Excel, Word, Outlook)
- Knowledge of Lotus Notes and Oracle a plus.
What's on Offer
Competitive salary, annual bonus, full benefits and relocation if necessary