Position Summary

The Regulatory Affairs Manager will report directly to The Vice President of Research & Development.  This position will interact heavily with the respective Directors of R&D and Marketing for all product categories in North America as well as International markets.  Additionally, heavy interaction and cooperation with the Legal and Quality Assurance Department is a daily expectation for this position.

The Regulatory Affairs Manager prepares, reviews, compiles, and submits domestic and international regulatory filings. The candidate may also participate in the preparation of international product registrations with in-country managers. He or she monitors and tracks information of individual country requirement changes and maintains departmental databases and filing systems for regulatory submissions and related documents.

The Regulatory Affairs Manager works independently on most assignments, utilizing information from multiple sources to solve moderately complex problems. The candidate exercises independent judgment and decision making on matters within standard company policies and regulatory requirements.

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Qualifications

·         BS degree in Chemistry, Pharmacy or Related Science

·         MS degree in QA/RA or related

·         At least 5 years experience in the vitamin/supplement/cosmetics industry with regulatory submission experience.

·         Strong QA background and familiarity with cGMPs, FDA guidelines and current standards used in the industry (ANSI, ISO, Mil, Federal).

·         Excellent technical writing and verbal communication skills.  Must be able to communicate effectively (verbal and written) and be proficient in Microsoft Office (Word, Excel or Access, PowerPoint).

·         Exceptional interpersonal skills with the ability to work independently, as part of a team and/or with external regulators.

·         The ability to speak/translate Korean, Japanese, Mandarin would be a definite positive in addition to the above qualifications.

Essential Duties & Responsibilities

·         Receives timely domestic and international product approval for the Marketing Department.

·         Coordinates and prepares technical files/design dossiers for domestic and international country registrations

·         In addition to the required technical documentation, he/she will also supply samples, packaging, manufacturing site quality system certificates, and certificate of free sale, etc.

·         Maintains and updates the International Country Registration Database

·         Maintains Regulatory Library with copies of all country registration files. Amends and updates as necessary

·         Using standard programs and systems, ensures accuracy and completeness of regulatory submissions, filings and tracking methods

·         Reviews initial product labeling and marketing materials to ensure compliance with the specific country labeling requirements