Regulatory Affairs Careers

Regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.

Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorised medicinal products.

Professionals in many cases form the link between pharmaceutical companies and regulatory authorities, such as Health Canada and the Food and Drugs Agency (FDA) and the European Union. At the company, they interact with the Research and Development (R&D), compliance and manufacturing staff to communicate their interpretation of federal and local guidelines. Agents must be sure the actions and vision of all departments are in concert and that this behavior is in accordance with the law.

Regulatory Affairs is an attractive career choice for graduate students from a
scientific background who enjoy communication and team work, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the Pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies.

Functions of Regulatory Affairs

Those looking for a role in regulatory affairs should have a strong understanding of the sciences and they should possess good business acumen. As with any job in the pharmaceuticals industry, a position in regulatory affairs requires a high level of written and oral communication and strict attention to detail.

Regulatory affairs consultants may work in various sectors, including pharmaceuticals, biotechnology and medical devices. Their tasks may include managing product licenses and labelling requirements, as well as developing relationships with distribution partners

Specifically Regulatory Affairs professionals perform the followings

  • Act as a liaison with regulatory agencies
  • Preparation of organized and scientifically valid regulatory submissions
  • Contract research organizations (CROs)
  • Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines,
    regulations and laws
  • Providing regulatory expertise in translating regulatory requirements into practical workable plans
  • Advising the companies on regulatory aspects and climate that would affect their proposed activities

Regulatory Affairs Professional Salary Range

Typically a starting salary for entry level/Junior RA associate is around $45k plus benefits.

If you are interested in pursuing quality assurance jobs specially in the pharma, biopharma, cosmetics, medical devices, food, and related industries do contact us at info@aaps.ca