Regulatory Affairs

Job Title

  • Regulatory Affairs Associate

Educational Background

  • B.Sc.
  • B.A.

Job Functions

The main job function is preparation of submission/application to regulatory agencies mainly to obtain approval for clinical trials and to obtain approval to market a new drug.

RA Associate responsibilities

  • Prepare regulatory submissions/applications for various markets and of quality for timely approval. (Note: the term submission is used in Canada and the word Application is used in the U.S.)
  • File the above prepared submissions/applications to the regulatory agency of the country where the drug product will be marketed (FDA for USA market and Health Canada for Canadian market)
  • Provide input into the development of submission strategies and work with others to negotiate with the country’s regulatory authority towards rapid approval with optimum labeling
    • submission strategies such as how to word the submission and how to best present the data to the regulatory authorities
  • Responsible for assessing deficiency letters from the regulatory authority and coordinating and compiling responses within the allowed time line.
  • Resolves regulatory issues raised internally or by government agencies by working with other departments. Initiate corrective action as required
  • Communicate with external parties such as suppliers to request data relevant to submissions
  • Prepare and review labeling, product monographs and marketing materials
  • Assist in product launch activities
  • Interpret and make decisions relating to regulatory guidelines and policies
  • Ensure compliance with company’s Standard Operating Procedures (SOPs), RA policies and procedures and regulatory guidelines
  • Prepare and draft SOPs
  • Keep abreast of regulatory updates in order to adjust the filing strategies and to be in compliance

Must Have Skills

  • Strong written and verbal communication, interpersonal and organizational skills
  • Attention to details
  • Able to meet timelines and work in a an environment with tight deadlines.
  • Knowledge of regulatory submission and the related terms
  • Must be proficient and comfortable working with electronic systems and with word, excel, PowerPoint
  • Comfortable doing paper work sitting at a desk on regular basis
  • Honest and transparent
  • Able to work in a team with different personalities and also able to work individually
  • Able to communicate information clearly to others

Type of Companies that hire

  • Pharmaceutical/ Biopharmaceutical
  • Biotech
  • Medical Device Companies
  • Regulatory Agencies
  • Cosmetic companies

Competitive Advantage

FYI

Career Growth

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