Navigating Careers in Regulatory & Medical Affairs: Insights from LSCDS’s 1st Mini Networking Night

The first mini-networking night held by the LSCDS networking team brought together students and recent graduates with eight professionals in regulatory and medical affairs, offering a unique opportunity to explore these careers. Attendees gained valuable insights into the different pathways to these roles, including the day-to-day responsibilities and challenges. Each professional shared their career journey, discussed the core demands of their roles, and provided practical advice on transitioning from academia to industry.

The professional guests were:
-Dr. Michelle Dubinsky - Boehringer Ingelheim Canada
-Dr. Ayda Shahidi - Bausch and Lomb
-Dr. Leslie Madden - Moderna
-Dr. Shariq Mujib - Regeneron
-Dr. Parinaz Akhlaghi - ILac
-Nathan Rutherford - Baxter International
-Dr. Carla Knezevic - AstraZeneca
-Dr. Meghan Wing-Hoffmann - La Roche

Regulatory affairs (RA) is a critical function in the healthcare and pharmaceutical industry, responsible for ensuring that products, such as pharmaceuticals, medical devices, and cosmetics, comply with regulatory standards to enter and remain on the market.

The RA speaker at the event explained that their role involves two key areas, product approval and product lifecycle management:

• Product Approval: Regulatory professionals compile and submit extensive documentation, including manufacturing data, ingredient safety, clinical results, and labeling information to health authorities like Health Canada. This process typically takes about a year and involves ongoing
  communication to address questions and concerns from regulatory bodies.

• Product Lifecycle Management: Once a product is approved, regulatory affairs professionals continue to oversee any significant changes, such as updates to manufacturing equipment, ingredient sources, or labeling. Some changes, especially those affecting safety or efficacy, require additional approval, while others may only require internal documentation. RA professionals often work closely with departments such as clinical, manufacturing, and legal, to ensure continued compliance.

The RA speaker noted that success in regulatory affairs is often measured by regulatory outcomes, such as obtaining a Notice of Compliance (NOC) from Health Canada. Additionally, professionals in RA may gauge successbased on how efficiently they navigate approval processes and identify opportunities to expedite product launch timelines.

The RA speakers suggested different entry pathways, including obtaining certifications in regulatory affairs offered by institutions such as Seneca College. These programs are generally short and often include co-op placements, providing practical industry experience. They also mentioned that these certificates are beneficial but not necessary.

Medical affairs is a vital function within healthcare and pharmaceutical companies that bridges the gap between clinical research and real-world medical practice. Professionals in medical affairs oversee a wide range of activities, from the early stages of product development to post-market evaluations, ensuring that scientific information about products is accurate, accessible, and aligned with regulatory standards. For example, the speaker in medical affairs described the role as involving everything from ideating new products to supporting them after they are launched, collaborating closely with clinical, regulatory, and commercial teams.

A Medical Science Liaison (MSL) is a field-based role within medical affairs that focuses on facilitating scientific exchange between a pharmaceutical or healthcare company and healthcare providers, including key opinion leaders (KOLs) and external experts. MSLs act as scientific ambassadors, engaging in non-promotional discussions about the company's products, recent data, disease mechanisms, and potential treatment options. Their goal is to support healthcare professionals by providing the latest research insights and gathering feedback.

Dr. Michelle Dubinsky described the typical day for an MSL, which involves traveling between healthcare institutions to meet with key opinion leaders (KOLs) and external experts. The day often starts early, attending grand rounds or similar educational meetings where they engage with medical professionals about the latest research and clinical data. MSLs may have multiple meetings throughout the day, discussing educational gaps, exploring potential collaborations, and gathering insights on healthcare practices and treatment challenges. Between meetings, they might drive to different locations or take time to catch up on documentation and prepare reports on their interactions.

Dr Shariq explained that success as an MSL is challenging to quantify but ties back to the impact on patient care and the value brought to healthcare providers.

One of the speakers in medical affairs described their medical manager roleas strategy-focused, typically head-office-based, and involving the creation of strategies for medical education and communication, developingprograms to address educational gaps and aligning strategies across different teams.

All speakers emphasized that career paths can be non-linear. For example, Dr Parinaz Akhlaghi highlighted the importance of embracing diverse experiences. She began her journey with a degree in Pharmacy from Iran, then earned a PhD in Chemical Engineering from the University of Waterloo. She moved to Brazil for a postdoctoral position in Chemistry, where she continued her work on novel drug delivery formulations. She then worked as a Scientific Affairs Manager at a UofT spinout startup, taking a product from bench to clinic. Now, she follows her passion for teaching regulatory affairs and clinical research while consulting for pharmaceutical start-up companies.

Dr. Ayda Shahidi advises that career paths can be unpredictable and emphasizes the importance of not trying to map out an exact trajectory before starting a role. She recounted her experience of initially pursuing a faculty position, finding it unsuitable to her career aspirations, and then transitioning to the industry as an MSL. She now works as a medical affairs manager. She highlights the importance of ensuring that roles align with one’s personality and interests.