Highlight your knowledge of regulatory requirements

Employers want to see that you have a solid understanding of the regulatory landscape and requirements relevant to the company's products and industry. Showcase your knowledge by:

• Discussing specific FDA regulations you've worked with, like 21 CFR Part 11 for electronic records
• Mentioning guidelines you're familiar with, such as Good Clinical Practices (GCP) or Good Manufacturing Practices (GMP)
• Highlighting any training or certifications in regulatory affairs, like RAC (Regulatory Affairs Certification)

Avoid simply listing terms without context, like this:

• Familiar with FDA regulations
• Knowledge of GMP and GCP

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   Demonstrate your attention to detail

Regulatory affairs requires a high level of accuracy and attention to detail. Show employers you have this skill:

• Mention specific details you caught that prevented costly errors, like identifying discrepancies in 100% of clinical trial data before submission
• Highlight your experience creating and reviewing detailed documentation, such as SOPs, BMRs, or regulatory submission documents
• Quantify your results, like 'Ensured 100% accuracy and compliance of 50+ CMC documents'

Don't just say you have strong attention to detail. Prove it with concrete examples of how you've applied this skill in past roles or projects.

   Showcase your communication and collaboration skills

Regulatory affairs associates work cross-functionally with teams like R&D, manufacturing, and quality assurance. Emphasize your ability to collaborate and communicate effectively:

• Mention project teams you worked with, like 'Collaborated with 5 different departments to compile IND submission'
• Highlight communication skills, such as 'Distilled complex regulatory information into clear, concise training materials for 100+ employees'
• Discuss how you managed competing priorities, like 'Coordinated 3 simultaneous regulatory submissions, ensuring on-time filing'

Avoid generic statements that don't tell employers much, like:

• Team player
• Strong communication skills

   Include relevant projects and internships

For entry-level positions, employers don't expect extensive regulatory experience. Including relevant projects, internships, or volunteer work can help you stand out:

• Discuss school projects related to regulatory affairs, like 'Developed a mock 510(k) submission for a new medical device as part of senior capstone project'
• Highlight relevant internships, such as 'Completed 3-month internship at Pfizer, assisting with preparation of IND and NDA submissions'
• Mention any volunteer experience, like 'Volunteered with AmeriCorps, ensuring program compliance with federal and state regulations'

Even if your experience isn't directly in regulatory affairs, showcasing transferable skills and knowledge can help you get your foot in the door.

   Tailor your resume to the job description

Customize your resume for each job you apply to by mirroring the language and requirements listed in the job description. For example:

• If the job mentions specific regulations, highlight your experience with those same regulations
• If the posting emphasizes certain skills, like project management or data analysis, feature those prominently in your resume

Compare this generic, untailored resume summary:

Recent graduate with a degree in Regulatory Affairs seeking an entry-level position. Strong knowledge of FDA regulations and experience with regulatory submissions.

To a tailored one that mirrors the job description:

Recent graduate with a B.S. in Regulatory Affairs and experience preparing IND and NDA submissions. Skilled in data analysis and project management, with a strong understanding of regulations like 21 CFR Part 11 and GxP guidelines.

   Quantify your achievements

Whenever possible, use numbers and metrics to quantify your achievements and make your resume more impactful. For example:

• Instead of 'Assisted with regulatory submissions,' say 'Contributed to 3 successful IND submissions and 2 NDAs'
• Rather than 'Reviewed batch records,' write 'Reviewed and approved 500+ batch records, ensuring 100% compliance with GMP requirements'
• Don't just say 'Created SOPs,' mention 'Wrote and implemented 15 new SOPs, reducing deviations by 25%'

Quantifying your experience gives employers a clearer picture of your skills and accomplishments. It helps them understand the scope and impact of your work.

Compare a bullet without metrics:

• Participated in internal audits

To one with quantified results:

• Assisted with 10 internal audits, identifying 50+ areas for improvement to ensure compliance with FDA regulations