Professional Regulatory Affairs Resume Examples & Guide for 2020

Volen Vulkov Avatar
Volen Vulkov
8 minute read
Updated on 2020-01-30

This FREE Regulatory Affairs resume example combines job responsibilities, experience, achievements, summary of qualifications, technical skills and soft skills generated from a database of successful resume models.

Use the Regulatory Affairs resume sample below, replace the information with relevant data about you and match your skill set, certificates and experience with the job description.

Cathy Rodgers
+359 88 888 8888
help@enhancv.com
Moscow, Russia
Experience
Regulatory Affairs Manager BiologicalsHerman LLC
2017 - Ongoing
Moscow, Russia
Herman LLC is a British pharmaceutical company manufacturing vaccines and products for major disease areas such as asthma, cancer, infections, diabetes and mental health
Reviewed around 15 Drug master file(DMF) for ANDA preparation
Charted ISO 13485 quality management system (QMS) and regulatory pathway for medical device, class III
Extended Business Trip (2 months) stay in Hong Kong working on a large submission of a key product
Assisted on business plan that gained 2+ million Euros to preclinical trials and product development
Achieved 100% RA/QA compliance with product amendments and acquisition of ATCL/TIC (distributor)
REGULATORY AFFAIRS TECHNICIAN QRVI (Quality, Regulatory, Vigilance, Medical information)Bernier
2013 - 2017
Moscow, Russia
Bernier is the third-largest French pharmaceutical laboratory, specialized in pharmaceuticals, health and dermo-cosmetics.
Promoted 3 times within the company
Promoted 3 times within the company
Trained nurses with Baxter products in over 3+ hospitals
Research Associate, Regulatory AffairsHerman LLC
2011 - 2013
Moscow, Russia
Herman LLC is a fourth largest Indian pharmaceutical company and 9th largest generic company in U.S. in terms of prescriptions
Placed 2 candidates in the medical devices sector with Sonosite and Stago in Paris.
Prepared and submitted over 50 Prior Approval Supplements, CBE-30, CBE-0 and annual reports
Coordinated 15+ major medical product recalls
Promoted 3 times within the company
Intern Regulatory AffairsLessard
2007 - 2011
Moscow, Russia
Lessard is an international company which aims to make the world a more efficient and sustainable place, by providing new technologies to improve the future of agriculture.
Reviewed and re-branded product labelling for compliance to TGO69 for all brands
Complied approximately 20 ANDA in eCTD format
Managed rotating team of 8 people
Education
Bachelor of Arts in SpanishMount Union
2006 - Ongoing
M.B.A. in Business ManagementUnited States University, San Diego
2002 - 2006
GPA
3.94 / 4.00
Languages
EnglishProficient
FrenchBeginner
Strengths
Genuinely Empathetic
high level of emotional intelligence used to understand and achieve the stakeholders objectives Team player: either we win or we lose together

Go through our full resume header guide for extra insights.

Additionally, you may also highlight awards, education, certifications and industry expertise, or include a career summary in your Regulatory Affairs resume that best portrays your professional work experience.

Courses
The Effective Facilitator
Leadership Strategies
RIGHT

What phrases to use in my Regulatory Affairs resume skills

  • Excel
  • Microsoft Office
  • SQL
  • Word
  • PySpark
  • Data Mining
  • APIs

How to feature Regulatory Affairs resume skills

How to use Excel in your Regulatory Affairs resume:

Developed excel macros to automate the creation of tables and charts for data analysis

How to use SQL in your Regulatory Affairs resume:

Engineered a python based data gathering solution to harness data from SQL, CSV and Excel files, and Prevalent APIs with Python and Postman

How to use Word in your Regulatory Affairs resume:

I have demonstrated competence in the use of word processing software, spreadsheet composition, creation of slide shows, and drafting of emails to be sent to customers or other departments.

How to use Data Mining in your Regulatory Affairs resume:

Engineered a python pandas based data mining solution to harness data from tools, files, and APIs

How to use Python in your Regulatory Affairs resume:

Ensured data tidiness and data quality in Python and Pandas

How to use Project Management in your Regulatory Affairs resume:

Project management of medical device design and development.

How to use NLP in your Regulatory Affairs resume:

Feature Engineering for NLP algorithms

* Data reflects analysis made on over 1M resume profiles and examples over the last 2 years from Enhancv.com. Use this Regulatory Affairs resume sample as a base to create a unique resume for yourself.

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