As a key member of the Quality Assurance and Regulatory Affairs team, the incumbent will:
Ensure international and domestic regulatory compliance for all products;
Support global market expansion through early identification of applicable product standards and regional and/or national regulatory requirements;
Prepare requisite regulatory submission to Regulatory Authorities and/or Ministries of Health;
Ensure regulatory compliance for all product labeling and promotional material including internet copy.
Duties and responsibilities
Regulatory Manager: International Compliance and Market Expansion
Lead regulatory activities required to obtain, prepare and submit requisite documentation for cosmetic product notification to the EU Representative;
Prepare INCI labeling for Global compliance;
Prepare and submit OTC drug submissions and cosmetic product notifications to Health Canada;
Establish and manage regulatory submission to Therapeutic Good Administration for AU;
Prepare regulatory documentation and manage the notification process for dietary supplement products across the globe;
Support international growth by obtaining/preparing the requisite documentation for product registrations/notifications and throughout the regulatory life cycle management process;
Review all product labeling and promotional material for compliance with applicable standards and regulations;
Prepare Drug Fact Box content for OTC labeling in the US and Canada;
Review all Internet content for regulatory compliance to ensure alignment of copy with corresponding product notifications, licenses and regulatory approvals;
Support global market expansion with submission of regulatory, technical and quality documentation to retail agencies such as QVC, HSN, WERCS, etc.
Work in a collaborative manner with the NPD and Marketing teams to preempt regulatory hurdles at the onset of development and develop corresponding regulatory strategies that will ensure compliance with
Bachelor’s degree in Pharm D. RAPS certification.
5-10 years of experience in the pharmaceutical, personal care, dietary supplement or medical device industry;
Working knowledge of OTC drug, cosmetic and Class 1 and 2 medical device regulations in the US and Canada;
Working knowledge of the EU Cosmetic Regulation and Notification Process, Packaging Regulation as well as experience with the ASEAN Cosmetic Directive;
Prior direct experience in dealing with the FDA and Health Canada with respect to audits and regulatory submission approvals;
Ability to summarize technical data and prepare regulatory submissions, documents and reports;
Excellent written and oral communication skills;
Strong interpersonal skills that enable the incumbent to work effectively and in a collaborate manner across all Image teams in a very fast-paced environment;
Agile and flexible in the ability to quickly accommodate changes in direction, product launches, retailer demands, consumer demands as well as the dynamic global regulatory landscape.
Additional Salary Information: $55 - $65 / hr.
Internal Number: RCPM001
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