Regulatory Affairs Associate – Submissions & Compliance

Efficient Auditing; Austin (TX); On-site; USD 70,000 - 110,000; Full time

Job summary

Efficient Auditing is seeking a Regulatory Affairs Associate to support regulatory submissions, compliance documentation, and product lifecycle management for clients across pharma, medical devices, biotech, and food industries.

The role involves monitoring global regulatory changes, ensuring programs meet FDA/EMA/ISO/GMP standards, and collaborating with R&D, Quality, and Manufacturing teams to gather data for submissions. Strong documentation and proactive regulatory mindset are essential.

Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Biotechnology, or related field.
• 1–4 years of regulatory affairs, compliance, or quality systems experience.
• Basic knowledge of FDA, EMA, and international regulatory frameworks.
• Strong documentation, organizational, and communication skills.
• Ability to analyze technical data and interpret regulatory requirements.

Responsibilities

• Assist in preparing regulatory submissions such as 510(k), DMF, ANDA, CE Marking documentation, and product registration dossiers.
• Review and maintain regulatory files including technical documentation, risk assessments, labeling, and quality records.
• Monitor regulatory updates from FDA, EMA, MHRA, Health Canada, and other authorities to ensure ongoing compliance.
• Support clients in developing regulatory strategies for new and existing products.
• Collaborate with R&D, Quality, and Manufacturing teams to gather data for submissions.
• Ensure compliance with global standards such as ISO 9001, ISO 13485, GMP, GDP, and GLP.
• Assist in responding to regulatory agency queries, observations, and inspection requirements.
• Provide regulatory input for product changes, validation activities, and quality improvements.
• Maintain accurate documentation and support internal/external audits as needed.

Skills

Regulatory knowledge

Documentation

Analytical skills

Communication skills

Education

Bachelor's degree in Regulatory Affairs/Life Sciences/Pharmacy/Biotechnology

Tools

QMS platforms

eCTD knowledge

Job description

Efficient Auditing is seeking a Regulatory Affairs Associate to support regulatory submissions, compliance documentation, and product lifecycle management for clients across pharma, medical devices, biotech, and food industries.

The role involves monitoring global regulatory changes, ensuring programs meet FDA/EMA/ISO/GMP standards, and collaborating with R&D, Quality, and Manufacturing teams to gather data for submissions. Strong documentation and proactive regulatory mindset are essential.