Your Future With Rochem
At ROCHEM we are dedicated to creating an environment where individuals can bring their unique talents to be welcomed and embraced. Our employees are truly the cornerstones of our success. You will enjoy our team spirit and the opportunity for your continued professional growth.
At ROCHEM it is not just a job, it’s a career. If you are a motivated and focused individual looking for a challenging and rewarding career then consider joining our professional team.
Regulatory and Compliance Associate
- In coordination with the China staff and/or suppliers, maintain and create, completed customer survey/questionnaires, product certifications, and provide customer requested documentation in a timely manner
- Act as a conduit between suppliers and to provide required regulatory, quality, and technical information in a timely and complete manner.
- Responsible to file, organize and maintain Regulatory department databases
- Assist in handling various customer complaints following prescribed in house SOPs.
- Assist in filing and maintaining product and facility registrations with FDA and/or NY State for pharmaceutical and nutritional ingredients
- Review product Certificates of Analyses for compliance to approved specifications.
- Work with the logistics group to provide necessary product intended use letters and resolve FDA related import issues.
- Support the relationship management of both suppliers and customers, as needed
- Carry out new project initiatives (Quality/Regulatory or otherwise) as directed by senior management
- Additional tasks/projects as determined/assigned by Rochem’s management team.
- Bachelor degree in a scientific, pharmaceutical, or quality related field.
- 2-5 years minimum experience in the Pharmaceutical and/or Nutritional industries in a Laboratory, Quality Assurance, or Regulatory related role.
- Experience in pharmaceutical/nutritional manufacturing and laboratory operations is desirable.
- Direct experience with filing product and facility NDC registrations, DMFs, COSs and dealing with FDA/EDQM is desirable.
- Bi-lingual in English/Chinese a plus.
Must be highly conscientious, have willingness/desire to learn, and a continuous improvement mindset.
Job Type: Full-time
- Monday to Friday
- relevant: 3 years (Required)