Regulatory affairs are a set of guidelines followed by various organizations. Their business needs to be regulated in order to provide high quality goods and services. This is important because products and services such as medicines, cosmetics, energy, etc., have a direct impact either on human beings and/or environment. Even industries such as telecommunication operate under the supervision of regulatory bodies that help its proper use and avoiding any misuse. An associate director of regular affairs is thus an important employee who helps in controlling the operations of these industries.
An associate director of regulatory affairs is primarily responsible for assisting the regulatory affairs manager. He may work in the organization itself or in an agency that provides regulatory affairs framework development services. In both the cases, he has to support the regulatory framework team and provide technical guidance to the team members and clients as well. He has to keep the team updated with the regulatory framework applicable for the business and product development life cycle.
The associate director of regulatory affairs is expected to drive the team and oversee documentation and submission. He has to participate in the product development process and prepare reports for review and audit. He also helps in getting licenses for products that have been manufactured and are ready to be sold in the market.
Given below is a simple description of the responsibilities of associate director of regulatory affairs working in a pharmaceutical company.
Provide Updated Regulatory Framework
An associate director of regulatory affairs is expected to stay updated with the recent amendments in the regulations stated by the authorities. This is very crucial for a product life cycle development process. If the most updated regulations are not followed, it may result in loss and project failure.
Lead Documentation Process
An associate director of regulatory affair leads the team members in the process documentation for all phases of product development. Upon completion of documentation, he publishes the documents or submits them to the regulatory bodies for approval. He maintains copies of approved documents for further reference.
Participate in Product Research
An associate director of regulatory affairs participates in the preliminary research.
Lead Clinical Trials
An associate director of regulatory affairs participates in the clinical trials to ensure that all the regulations are followed. It also helps him to review the time and resources consumed for each process.
Conduct/Support Audit Process
An associate director of regulatory affairs conducts audits during the product development or assists the audit staff by providing documents for reference.
The skills an associate director of regulatory affairs must possess are listed below:
An associate director of regulatory affairs is usually an individual with a degree in the domain he chooses to work in. Previous experience of working in various projects of product life cycle development or even in a similar service industry helps a lot to learn about the regulations followed in the industry.
An associate director of regulatory affairs earns $1, 00,000 on an average. Salaries vary largely due to difference in industry, location and on the candidate's competency as well.
Associate director of regulatory affairs responsibilities draw an illustration that explain not just the duties of this job, but also the skills and knowledge required to work in this position.