Regulatory Affairs Associate

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

We are seeking a detail-oriented Regulatory Affairs Associate to support regulatory submissions, compliance documentation, and product lifecycle management for clients across pharmaceuticals, medical devices, biotech, and food industries. The ideal candidate will assist in preparing regulatory submissions, monitoring global regulatory changes, and ensuring products and processes meet applicable standards such as FDA, EMA, ISO, GMP, and other international guidelines. This role requires strong analytical skills, excellent documentation abilities, and a proactive approach to maintaining regulatory compliance.

Key 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.

Qualifications

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

Preferred Skills

• Experience with medical device regulatory submissions (510k, CE MDR).
• Knowledge of eCTD, risk management, and technical documentation preparation.
• Understanding of GMP, GDP, and ISO standards.
• Ability to work independently and handle multiple deadlines.

Why Join Us?

• Work directly with global clients in highly regulated industries.
• Gain hands-on experience with diverse regulatory submission types.
• Excellent opportunity to grow into senior regulatory or compliance roles.
• Supportive environment with continuous training and professional development.
• Engage in meaningful work that supports product safety and compliance worldwide.