With the Rise of Regulatory Science… ‘RA’ Has Also Surged in ImportanceThe industry identifies RA as a specialized profession whose importance has recently grown. In the past, it was widely perceived as merely the role of preparing marketing authorization documents to be submitted to the Ministry of Food and Drug Safety.
However, as overseas clinical trials and global approvals have increased, the scope of their work has changed. They must integrate clinical trials, non-clinical studies, statistics, and manufacturing and quality control (CMC) and safety data into a single development strategy that reflects the standards required by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). If the regulatory pathway is poorly designed from the early stages of development, it may be necessary to conduct additional clinical trials or re-generate data.
At smaller biotech companies, Quality Assurance (QA) staff sometimes handle some RA duties as well. In contrast, traditional pharmaceutical companies with a large number of marketed products and regulatory change requests often maintain a separate RA organization. This is why the roles are primarily filled by pharmacists or individuals with master’s or doctoral degrees in pharmacy or life sciences.
A researcher currently employed at a biotech company stated, “While QA staff at small companies may handle some RA tasks, pharmaceutical companies generally operate separate RA organizations,” adding, “They often prefer pharmacists or those with master’s or doctoral degrees in related fields and require a certain level of experience, so it is not easy for new graduates to enter the field immediately.”
The pay gap is also widening depending on expertise. Based on a review of public job postings and industry briefings, the annual salary for entry-level or junior RAs at domestic pharmaceutical and biotech companies ranges from approximately 35 million to 50 million won, while those with five or more years of experience earn around 50 million to 70 million won. However, there is a significant difference between staff responsible for maintaining domestic product approvals and global RAs. Team leaders with a pharmacist license or global work experience are reportedly paid well above the general range.
RA is not a newly emerged job category. The Ministry of Food and Drug Safety (MFDS) has been operating training programs for professionals in pharmaceutical regulatory affairs since 2014. However, as regulatory compliance has expanded from simple document preparation to “regulatory science”—which involves designing development strategies—there has been a growing movement to systematically cultivate specialized talent.
Starting in 2021, the MFDS began a program to cultivate master’s and doctoral-level talent in regulatory science by selecting partner universities. In 2022, it expanded the scope of training to include pharmaceutical manufacturing and quality control, medical device safety and efficacy, and regulatory policy. At that time, the agency set a goal of training 600 master’s and doctoral-level professionals and 9,800 field-level regulatory experts over a five-year period.
BD Professionals in High Demand Across the IndustryWhile RAs have emerged as a rising profession within the pharmaceutical and biotech sectors, from the perspective of the industry’s overall labor supply and demand, business development (BD) professionals are drawing attention due to staffing shortages. In particular, while some professionals with domestic business development experience have been secured,
globalBD professionals—those with experience in direct negotiations with global pharmaceutical companies and in technology transfer or joint development—are still considered rare.
A bioindustry official stated, “While there is high demand for RAs as well, the demand is being partially met by professionals with regulatory or compliance experience moving into the field,” adding, “Global BD is a role where demand is high but the supply of qualified candidates is low, so it is drawing even more attention than RA in terms of concerns.”
The upper end of the salary range is also relatively higher for BD professionals. Recent job postings from biotech companies for BD professionals with 5 to 10 years of experience listed annual salary ranges of 50 million to 100 million won. Entry-level BD professionals are estimated to earn 40 million to 55 million won, while mid-level professionals capable of independently conducting partner identification, due diligence, and contract negotiations are expected to earn around 100 million won. Analysts note that it is not uncommon for team leaders or executives with a track record of overseas technology transfers to earn well over 100 million won. In addition to base salary, BD professionals often receive performance bonuses or stock options tied to closing deals, meaning their actual compensation levels are reportedly much higher than these figures suggest.
The fact that domestic biohealth companies still have limited experience expanding overseas supports the shortage of BD personnel and the rise in their compensation levels. According to a 2024 survey by the Korea Health Industry Development Institute, only 24% of pharmaceutical, medical device, cosmetics, and functional food companies had experience expanding overseas. Among the 18,990 companies in the survey sample, small and medium-sized enterprises (SMEs) accounted for over 95%. Key challenges in the process of expanding overseas included not only funding but also regulations, market access, and local certifications.
As a result, it is common for consulting firms selected through government-funded projects to act on behalf of companies lacking their own BD personnel, handling the identification of overseas partners and organizing partnering events. Another bio industry official explained, “When you visit the evaluation sites for government-funded projects, you’ll find quite a few initiatives that select external firms to perform BD functions on behalf of biotech companies,” adding, “The fact that there is a shortage of global BD personnel within companies is also evident in the government’s support structure.”
He continued, “Since there aren’t many people with direct experience in global collaboration, it’s common for companies to recruit executives who previously handled BD at overseas pharmaceutical firms,” adding, “Some companies even appear to rely on the overseas network and transaction experience of a single CEO or key executive rather than the collective capabilities of their entire BD team.”
Overcoming Regulations and Securing Deals… Leaders in RA and BDSo, which companies excel in RA and BD? Within the industry, RA capabilities are primarily judged by overseas clinical trial approvals and regulatory agency designations, while BD capabilities are assessed based on the caliber of global partners, upfront payments, and the presence of repeat contracts.
Orum Therapeutics is cited as a prime example. Orum secured a $100 million upfront payment by licensing ORM-6151—which received approval to enter Phase 1 clinical trials in the U.S. in 2023—to Bristol Myers Squibb (BMS). The following year, it also signed a technology transfer agreement worth trillions of won with Vertex Pharmaceuticals covering up to three targets. This is seen as a relatively clear demonstration of the company’s business development (BD) capabilities, as it successfully concluded a series of deals involving drug candidates and platforms with different global pharmaceutical companies.
Idian, a subsidiary of the Ildong Pharmaceutical Group specializing in the development of new anticancer drugs, serves as an example of RA and BD working in tandem. After securing approval for U.S. clinical trials of its lead candidate, Benadapalip, the company went through regulatory procedures such as obtaining orphan drug designation, and last year transferred rights for the Eurasian Economic Union and Gulf Cooperation Council regions for approximately 70 billion won. A key feature is how the company leveraged its global regulatory and development experience to secure technology exports in specific regions.
Fraser Therapeutics and Progenie are drawing attention. Fraser not only secured a 29 billion won investment led by a Johnson & Johnson-affiliated venture capital firm but also entered into a joint research and licensing agreement. This is a case where the company’s business development (BD) potential was recognized for successfully linking early-stage technology with strategic overseas investments and partnerships. Progenie also recently signed a technology export agreement worth up to $390 million with a U.S. biotech company to apply its immune-enhancing platform to four types of cancer vaccines.
