Moving from writing the documents into regulatory affairs
Moving from medical writing into regulatory affairs brings submission strategy and regulatory interpretation into greater focus. Experience with regulatory documents can support the move, but the work can require a different balance of strategic thinking, immediate decisions and interaction with colleagues.
Reasons for the move
In a career change described in 2013, a writer who enjoyed managing medical writers more than writing decided to move after five years in medical writing and began seeking regulatory tasks such as advising on submission structure. Her earlier work in preclinical pharmacology, clinical research and clinical-trial management also contributed to the skills she brought to the move.
Familiarity with regulatory dossiers can provide common ground between the two roles. Another writer described moving into regulatory-affairs work although he had never formally been a regulatory-affairs professional; preparing dossier sections and knowing the regulations governing clinical study reports, integrated summaries and applications provided an overlap between the roles. He reported convincing hiring managers that effective communication could compensate for a lack of experience in a particular discipline.
Knowledge and experience to develop
Preparation should extend beyond guidance on document format and content to the types of submission and the requirements for each. Reading those requirements can provide insight into submission strategy. In one transition, this meant supplementing familiarity with ICH M4 with study of the US regulations in 21 CFR Parts 312 and 314.
Four recommended steps for a writer considering the move are:
- Join the Regulatory Affairs Professionals Society (RAPS), whose career-development resources include classes and certification programmes.
- Seek opportunities to progress from study-specific documents, such as protocols and clinical and nonclinical study reports, to higher-level summaries and briefing documents. These help develop strategic thinking and offer experience more closely aligned with the writing tasks regulatory-affairs hiring managers seek.
- Emphasise transferable communication, interpersonal, time-management, prioritisation and teamwork skills, rather than lists of documents written or quality-control and editorial skills.
- Avoid making the move simply to gain colleagues' respect.
Changes in working culture
One writer's 2013 account of moving into regulatory affairs described a shift from objective, dispassionate reporting of facts to using those facts to devise creative strategies that could reduce review time or regulatory risk. She regarded creativity and risk-taking as valued in regulatory affairs but as qualities that would not endear a medical writer to clients.
Most writers she knew enjoyed solitary working conditions. Her regulatory-affairs role involved at least 40% of her time in meetings and another 20% answering calls from other departments about the regulatory implications of manufacturing changes. Answers were generally expected during the conversation, leaving less time for reflection and research. She also found regulations and guidance more open to interpretation than data, making “it depends” a frequent answer. The pace, social interaction and view of the wider development process were aspects of the new role she enjoyed.
Expectations of respect
One writer encountered chemists, biologists and physicians who treated medical writing as merely making their work look good, then found that some colleagues in regulatory affairs treated her objections to departures from guidance as a failure to understand their science. Her conclusion was that respect depended on the quality of the work rather than the type of work performed.