A Recap of ITCS Career Seminar on Medical Affairs and Regulatory Affairs Seminar
The LSCDS Medical Affairs and Regulatory Affairs Seminar is the second installation of the Career Seminar series. This event featured seven industry experts, who shared strategies that helped them navigate their transition from academia to the field of medical or regulatory affairs. The experts not only shared their personal journeys but also shed light on their day-to-day responsibilities. They offered an in-depth perspective on skills acquired during their graduate studies that were the most valuable for their current roles. Overall, the seminar provided an overview of the roles that regulatory and medical affairs play in steering the successful development, approval, and commercialization of healthcare products. Lastly, the seminar concluded with a Q&A session that sparked discussions such as the integration of artificial intelligence (AI) and its potential impact on the job market.
Regulatory Affairs – Regulatory affairs (RA) professionals work across various industries, including pharmaceuticals, medical devices, cosmetics, dietary supplements, and biotechnology. In the context of pharmaceutical companies, the RA department serves as an interface between the health/regulatory authority and project team to ensure compliance, safety, and efficiency, guiding products and services through the complex landscape of guidelines and ever-changing legislation. A key role of RA involves the preparation of the dossier. The dossier is a package of documents, which can include all required information regarding newly developed drug products and/or generics, required by health authorities for granting marketing authorization approvals submitted to the health authorities in the CTD (Common Technical Document) format.
The first RA speaker at the event detailed a drug submission case study, emphasizing the meticulousness required in RA. The role demands an interplay of adept time management and communication skills to efficiently collaborate with both internal and external stakeholders. The second RA speaker discussed various entry pathways such as college diploma programs and MSc co-op placements. To excel in the field of regulatory affairs, both speakers stressed the significance of strong analytical and research-oriented skills, effective project management abilities, and a robust understanding of regulatory frameworks.
Medical Affairs - The second segment of the seminar provided an understanding of the evolving landscape of medical affairs (MA) from a supportive function under commercial operations to an independent entity serving as a strategic partner to the broader organization. The primary role of MA is to communicate scientific and clinical information to the medical community. This communication serves as a bridge between pharmaceutical or medical device companies and healthcare providers, patients, and relevant stakeholders. Some of the key positions within MA include Medical Science Liaison (MSL), Medical Information, and Scientific Communications, among others.
The first speaker delineated these roles within MA and additionally highlighted the possible areas of growth and career trajectories. The MSL role necessitates strong interpersonal skills and scientific expertise whereas the medical lead/director roles typically require a deeper involvement in shaping the strategic direction of the product or therapeutic area. Expanding on the impact of MA teams, the speaker shared the six core domains which contribute significantly to the development lifecycle of an asset. These domains include Medical Leadership, Medical Strategy, Insights Generation, Evidence Generation, Scientific Communication, and External Engagement. The final two speakers of the night provided important insights into the roles of MSLs and medical advisors, respectively. They discussed their daily responsibilities, mentorship programs, networking, and the rewarding aspects of their roles. The latter discussion touched upon the continuous learning opportunities and the impactful contributions these professionals make for healthcare.
During the Q&A session, panelists addressed inquiries regarding career progression within the field, stressing on the complexity and steep learning curve associated with roles such as MSLs. The speakers also discussed the integration of AI in regulatory processes, noting its potential in streamlining repetitive tasks. To summarize, the seminar offered an all-inclusive overview of the multifaceted roles within MA and RA. Attendees gained valuable insights into career paths, skill requirements, and the evolving landscape of the industry. If you want to hear about more LSCDS events, please follow us on our social media – LinkedIn, Instagram, and Twitter! Stay tuned for upcoming career seminars this semester to learn about careers beyond academia and expand your professional networks!
