Manager of Regulatory Affairs
We are seeking an experienced regulatory affairs professional to manage our growing Regulatory Affairs needs. This candidate will execute all regulatory initiatives to support worldwide cosmetic and over-the-counter (OTC) drug product registrations, ensuring compliance with FDA and international regulatory agencies. This manager-level position will report to the Vice President of Technical Affairs and will have one direct report.

Essential Duties:
" Define and implement US and international regulatory strategies for topical cosmetics, over-the-counter drugs and physician peel reagents
" Ensure compliance with global regulations in order to support commercial sale
" Ensure global regulatory acceptability of new formulations and ingredients
" Manage the preparation and filing of regulatory documentation with domestic and international regulatory bodies including:
o Product information files (PIFs) with safety assessments
o Registration dossiers
o REACH submissions for new ingredients
" Review and approve labeling to ensure compliance with regulations
" Support medical device registration of peels
" Review and close adverse events, and prepare an annual pharmacovigilance report
" Work with document control to facilitate change control of regulatory documents in conjunction with Quality Assurance
" Anticipate and plan for changes in regulations and guidelines that may affect formulation, registration and documentation requirements in all markets
" Collaborate with Quality Assurance in driving compliance activities related to GMP/GLP/GCP quality standards
" Create and maintain SOPs specific to regulatory affairs and provide training to appropriate personnel
" Maintain facility registration with FDA; participate in FDA inspections

Minimum Qualifications:
" A Bachelor's degree in a scientific discipline
" 8-10 years relevant experience; experience in cosmetic dermatology is strongly preferred
" Established contacts with industry and trade associations a plus
" Strong, professional interpersonal skills including the ability to communicate effectively with individual colleagues and cross-functional teams; ability to manage other regulatory colleagues
" Highly proficient in Microsoft Suite including Excel, Access, and Word
" Must be a hard-working, entrepreneurial-minded, independent, adaptable self-starter who enjoys the hands-on environment of a small, dynamic company