- Title: Regulatory Affairs Associate (LATAM)
- Location: Gibbstown, NJ.
- Industry: Regulated Pharmaceutical and Medical Devices
- Experience: Mid-Level
- Shift: M-F, 8:30 AM – 5:00 PM
- Must Haves: MUST BE FLUENT in Spanish language – oral and written.
Essential Job Functions
- Responsible for management of product registrations in Latin American countries (Mexico, Central and South America countries) – including new product registrations, registration renewals, post-registration activities, registration updates / modifications, and managing labeling changes for both import and export to maintain quality standard, good manufacturing practices.
- Responsible for effective communication (oral and written) with Spanish-speaking regulatory authorities, distributors and License Holders in Latin American countries.
- Investigate / assess the requirements for product registration in each country, collect and prepare submission / dossier documents / technical data – and submit to regional RA consultants, distributors and/or regional regulatory authorities.
- Manage product registration processes and document requirements for each country.
- Identify, interpret and apply applicable regulations to support international product commercialization.
- Learn regional regulatory requirements and stay current on changing regulations.
- Develop / Update schedule of product registration and track submission progress, and share with product planning, marketing, sales teams and Regulatory Management.
- Provide regulatory support and recommendations on labeling, manufacturing, and analytical and clinical study issues for regulatory compliance.
- Address daily questions / issues / requests regarding product registrations and submissions from multiple parties.
- Manage budget for product registration in each Latin American country.
- As necessary, travel to Latin American countries for face-to-face meetings with local teams / consultants and agencies to discuss specific requirements and options to register products in each country.
- Actively support Keystone’s Product Development and Marketing Teams with introducing new products into Latin American communities.
- MUST BE FLUENT in Spanish language – oral and written.
- Demonstrated ability to effectively manage multiple projects.
- Capable of working in a regulated environment. (Industry experience a plus).
- Good business acumen
- Ability to quickly learn pharmaceutical and medical device regulations, as well as understand establishment of regulatory planning/strategies.
- Good problem-resolution skills – ability to “think outside the box”.
- Must be reliable and demonstrate a strong work ethic.
- Ability to work independently with minimal supervision as well as on a team
- Must have good technical writing skills and good oral communication skills.
- Strong computer skills.
- Must have four-year degree from accredited college or university – preferably in Business Administration, International Affairs, Operations Management or similar.
- Applicable work experience may be accepted in lieu of education requirements, but work experience must be sufficiently demonstrated