What is the role of a Regulatory Affairs Officer?

The position of Regulatory Affairs Manager is a crucial function within a pharmaceutical laboratory or medical device manufacturer.

The Regulatory Affairs Manager works closely with other departments of the company, including research and development, marketing and quality.

What are the duties of the Regulatory Affairs Manager?

The Regulatory Affairs Manager is responsible for a product portfolio. It is his responsibility to define and implement a regulatory strategy on this portfolio. He brings his contribution and his expertise to the negotiation of the conditions of the placing on the market of the products so that this one is done in the best conditions and as soon as possible.

The regulatory affairs programs in USA implements an effective strategy to ensure that the products placed on the market comply fully with the regulations in force. He is in charge of studying and evaluating the possible regulatory impacts of a modification on a product (formula, packaging).

The head of regulatory affairs is the interlocutor of the regulatory authorities and is responsible for responding to any request from them.

What is the path of a regulatory affairs manager?

  • To gain access to the position of Regulatory Affairs Manager, it is often required to have regulatory affairs certifications USA.
  • In addition, to become responsible for the regulatory affairs of an international pharmaceutical company, 8 to 10 years of experience in regulatory affairs is required. Management experience is also required.
  • Experience in an international context, including knowledge of FDA validation processes, is highly desirable. The Regulatory Affairs Officer must be fluent in English.
  • After several years in the position, the head of regulatory affairs can claim positions of high responsibility within the research and development department of the Pharmaceutical Laboratory.

What are the qualities of a Regulatory Affairs Manager?

The person responsible for regulatory affairs must carry out a permanent legal watch to be always aware of the regulations and legislation in force. In addition, it is a force of proposal within the Pharmaceutical Laboratory.

Pursuing pharmaceutical regulatory affairs course in USA requires a strong sense of rigor, organization, and initiative.

The head of regulatory affairs must be experienced in managing relations with the relevant administrative authorities. It must, therefore, have real relational qualities and communication.

Becoming a Regulatory Affairs Manager: Qualifications required

Given the technical nature of the business, the head of regulatory affairs must have extensive skills in the legal field to advise his company on the organizational strategy to adopt. Depending on the sector of activity for which he works, the regulatory affairs manager must have scientific knowledge adapted to the product to be developed in order to be able to decipher the technical documentation correctly. As such, a perfect command of the English language, in which most files are written, is essential, especially within a company with an international dimension. To accomplish his missions, the head of regulatory affairs must be rigorous to ensure serious application of the regulations in force. The spirit of synthesis is also an asset to exercise this business because it allows the consultant in regulatory affairs to make the most strategic choices. In relation with the administrative authorities, the head of regulatory affairs is an excellent communicator who knows how to develop and maintain a network of relationships.

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