Regulatory Affairs Associate Resume Sample

Overview

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


REGULATORY AFFAIRS ASSOCIATE

PERFORMANCE SUMMARY
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.

CORE SKILLS & COMPETENCIES

• 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

 

PERFORMANCE HIGHLIGHTS
• 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.

PROFESSIONAL EXPERIENCE

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.

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






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