Regulatory Affairs Associate Resume Sample


A Regulatory Affairs Associate resume is not like any other job application document – it is much more profound.

If yours isn’t, it is time that you made it so.

Here is a sample Regulatory Affairs Associate resume format that you can go through to base your own resume on:

See also: Regulatory Affairs Associate Cover Letter Sample



Regulatory Affairs Associate Resume Example



Willaim Ruffalo

750 Heather Lane, Eureka, CA 02188
(000) 999-5241 | willruff @ email . com


Highly enthusiastic and resourceful Regulatory Affairs Associate with extensive experience in ensuring that company products meet regulatory authorities’ regulations. Skilled in collecting, collating and evaluating data to provide well-placed findings, aiming to assist in regulatory compliance:

Develops and writes clear arguments and explanations for new product licenses. Determined and results-oriented with the ability to prepare submissions of license variations and renewals, to strict timelines.


• Data Gathering• Compliance Assurance• Trial Data Handling
• Marketing• Data Collation• License Renewals
• Clinical Study Reports• Change Management• Product Portfolio Oversight
• Pre-market Submissions• Material Review• Agency Liaison


• Successfully obtained licenses for 15 new drugs while ensuring that all metrics were adhered to.
• Implemented a data collation system which proved to be 75% more efficient than the one already in place.
• Efficiently liaised with a government body, effectively obtaining renewals for a drug that had been in limbo for 3 years.
• Devised a clinical study reporting system, which took 50% less time in developing reports.


Regulatory Affairs Associate
Alvogen, Eureka, CA | 6/2013 – Present

• Collaborate with other functional areas to obtain documentation for regulatory purposes.
• Assemble, prepare and submit original registrations, amendments, supplements, and variations.
• Prepare responses to action letters, and other agency requests, and prepare regulatory strategies.
• Keep up to date with international legislations, guidelines, and practices globally.
• Develop and write clear arguments and explanations for new product licenses.

Regulatory Affairs Associate
Some Company, Eureka, CA | 11/2007 – 6/2013

• Prepared submission license variations and renewals ensuring that strict deadlines were met.
• Gathered, collated, evaluated and organized information in a variety of formats, and ensure that it is properly indexed.
• Provided advice and suggestions about regulations to manufacturers, in a bid to help them comply with regulations.
• Demonstrated expertise in monitoring and setting timelines for license renewal approvals.
• Effectively planned and developed product trials and interpreting trial data.

Regulatory Affairs Intern
Exact Science, Eureka, CA | 2/2005 – 5/2007

• Assisted regulatory specialists in obtaining information regarding regulations and protocols.
• Researched documentation required to ensure compliance to government agencies and medical associations.
• Wrote explanations and outlines for company drugs, to provide authorities with information on their makeup.
• Outlined requirements of labeling, storage and packaging of company produced drugs and equipment.
• Assisted in the planning, undertaking and overseeing of product trials and regulatory inspections.

Eureka College, Eureka, CA – 2003
Bachelor’s Degree in Social Sciences

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