Regulatory Affairs Associate EnglishSpanish - 5TH HQ : Job Details

About the Role

We are seeking a Regulatory Affairs Associate to join our Quality team. This role is responsible for ensuring compliance with cGMPs, maintaining controlled documentation, and supporting audits and regulatory submissions. The ideal candidate is detail-oriented, organized, and eager to contribute to a fast-paced environment.

Key Responsibilities

• Create, review, and update controlled documents, including SOPs, specifications, testing methods, and validation reports.
• Manage distribution and control of SOPs, revisions, and related documentation.
• Coordinate change control activities and ensure compliance with company policies.
• Prepare and conduct GMP training based on the Training Matrix.
• Support vendor qualification by coordinating audit schedules and generating supplier audit reports.
• Assist in customer and regulatory audits; prepare CAPA responses.
• Maintain regulatory files and databases, ensuring accuracy, secure storage, and accessibility.
• Monitor processing status and archiving of master documentation.
• Collaborate with supervisors to ensure compliance with SOPs and regulatory requirements.
• Perform additional duties as assigned.

Qualifications

• Bachelor's degree in Science or related field, or equivalent experience.
• 1–3 years of regulatory, production, or QC experience.
• Knowledge of GMP regulations is required.
• Strong attention to detail and organizational skills.
• Computer literacy and familiarity with documentation systems.
• Bilingual (English/Spanish).

Schedule

• Monday to Friday | 8:30 AM – 5:00 PM