The Regulatory Affairs professional’s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labelling and advertising and post-market surveillance.
The regulatory function across healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance, are all considered regulatory professionals.
Regulatory Affairs professionals come from a diverse range of backgrounds. Most have earned a Bachelor’s degree, and more than half have an advanced degree – most often in a scientific or technical field. In addition, Regulatory professionals usually have experience in other careers before transitioning into Regulatory Affairs.
Although there are some university degrees and graduate certificate programs in Regulatory Affairs and related areas, experience is a key asset for Regulatory professionals. Valuable skills include project management and organisation, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organisation.
Continuing with education and professional development is critical to a Regulatory professional. They must keep up-to-date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products.
Regulatory Compliance: Regulatory Affairs professionals are responsible for ensuring that pharmaceutical products comply with all relevant regulations and guidelines. This includes everything from drug development and clinical trials to product labelling and advertising.
Liaison with Regulatory Agencies: They act as a bridge between the pharmaceutical company and regulatory authorities such as the European Medicines Agency (EMA) and other global agencies. They communicate with these agencies to gain approvals and resolve regulatory issues.
Documentation: They create and maintain comprehensive regulatory documents, including drug registration dossiers, to submit to regulatory agencies. This requires attention to detail and an understanding of scientific and medical terminology.
Product Development: Regulatory affairs professionals often work closely with R&D teams to ensure that new drug or medical device products are developed in compliance with regulatory requirements from the early stages of development.
Quality Assurance: They ensure that manufacturing and quality control processes meet regulatory standards to guarantee product safety and efficacy.
Post-Market Surveillance: After a product is on the market, regulatory affairs professionals monitor and report adverse events and product complaints to regulatory agencies as required by law.
Labelling and Packaging: They are involved in the design and review of product labels and packaging to ensure they meet regulatory standards and accurately represent the product.
International Regulations: For global pharmaceutical companies, regulatory affairs professionals must navigate and understand the regulations of various countries and regions.
A career path in pharmaceutical regulatory affairs typically follows a structured progression that may vary based on individual qualifications, interests, and the specific roles within the regulatory affairs field.
Regulatory Affairs Associate: Entry-level positions often begin as regulatory affairs associates. In this role, you'll assist in regulatory submissions, document management, and compliance activities. This is an excellent starting point to gain experience and understanding of regulatory processes.
Regulatory Affairs Assistant: This role involves providing administrative support to the regulatory affairs team, assisting with document preparation, and maintaining regulatory databases.
Regulatory Affairs Specialist: With a few years of experience, you can move up to the position of a specialist. This role involves more responsibility in preparing regulatory submissions, managing regulatory documentation, and liaising with regulatory agencies.
Regulatory Affairs Project Manager: As a project manager, you'll take on a leadership role in coordinating and managing regulatory projects. This may involve overseeing a team, ensuring compliance, and guiding product development with a regulatory perspective.
Regulatory Affairs Manager: In this role, you'll be responsible for managing a team of regulatory professionals and overseeing regulatory strategies for product portfolios. You'll also be more involved in decision-making and strategic planning.
Senior and Leadership Positions:
Senior Regulatory Affairs Manager/Director: At this level, you'll be responsible for the regulatory affairs department's overall functioning, setting departmental strategy, and managing senior regulatory staff. You may also play a significant role in regulatory strategy development.
Regulatory Affairs Executive/VP: In these executive positions, you'll have a strategic role in the organisation, advising on regulatory matters at the highest level. Your responsibilities will extend beyond day-to-day regulatory operations and may include interactions with top management, board members, and stakeholders.
Regulatory Affairs Consultant: Some professionals choose to work as independent consultants or within consulting firms. They provide regulatory expertise to multiple companies, helping them navigate the regulatory landscape and compliance issues.
Regulatory Affairs Training and Education: Some individuals transition into roles focused on training and educating others in the field. This may involve working at universities, conducting workshops, or developing educational materials.
Global and International Roles:
International Regulatory Affairs Specialist/Manager: As global markets expand, professionals who specialize in international regulatory affairs may focus on navigating the regulations of multiple countries or regions.
Regulatory Affairs Leadership and Advocacy:
Regulatory Affairs Association Executive: You can also explore roles within regulatory affairs associations, where you work on industry advocacy, policy development, and regulatory guidance.
It's important to note that a strong educational background and relevant certifications, such as the Regulatory Affairs Certification (RAC), can enhance your career progression. Networking, staying updated on regulatory changes, and gaining experience in different aspects of regulatory affairs are also crucial for advancement.
Throughout your career in Pharmaceutical Regulatory Affairs, you may choose to specialise in a specific area, such as medical devices, clinical trials, biotechnology, or drug development. The exact path can vary based on your interests and opportunities, but it's a field that offers a rewarding and dynamic career with potential for growth and influence.
Find out more about how to progress your Regulatory Affairs career here.