Industries ISA Brainstorming

• A regulatory affairs specialist manages drug approvals and ensures compliance with Health Canada [10]
• A CRA oversees clinical trials to test new medicines [11]
• A pharmaceutical sales representative promotes products to doctors and pharmacists
• You can work manufacturing/quality assurance and make sure drugs are manufactured safely and meet quality standards
• A research scientist does research to discover and improve medications

A Regulatory Affairs Specialist ensures pharmaceutical products meet government rules so they can be sold legally. Common tasks include:

• Preparing and submitting detailed documentation to regulatory agencies [10]
• Interacting with RD, compliance and manufacturing staff to communicate their interpretation of guidelines [10]
• Collaborating with scientists, engineers, and legal teams to ensure products follow CGMP and other regulatory standards. [10]
• Advising companies on regulatory aspects and climate that would affect their proposed activities. [10]

• Health Canada regulations can get complex and change over time. Specialists must stay current.
• Specialists must have great attention to detail. Small errors can delay approvals, so accuracy is crucial.
• Submissions often come with tight deadlines that require lots of planning.
• You must balance scientific and business perspectives. The role requires both scientific understanding and strategic communication with regulators and internal teams.

Regulatory Affairs Specialists have a wide salary range in Canada. Entry-level roles might start around ~$76,000 CAD, climbing to over $142,000 CAD with experience, and senior specialists can earn well over $176,000 [12]. The role has good job security because regulatory compliance is mandatory and companies cannot sell drugs without approval, making this job necessary. Also, the skills of regulatory affairs professionals are applicable across companies and even industries(medical devices, biotechnology, …). The ongoing need for approvals (new drugs, generics, biosimilars) helps sustain demand.

• The regulations have increased in complexity [13]. More global standards means professionals have to continually update their skills.
• The growth of generic and biosimilars increases regulatory workload for approvals of similar products [14]
• Specialized software has been adopted for submission. An example of this is the eCTD(Electronic Common Technical Document) format.

Canada is experiencing drug shortages, including shortages of prescription and sometimes non-prescription medications. These can happen due to manufacturing problems, quality control disruptions, shipping delays, and shortages of key ingredients. [16].

Shortages can threaten relationships with patients when the treatments they need are not available. They make it harder for pharmacies, hospitals, and distributors who have to manage limited supplies. Also, they can increase healthcare costs when alternative(often more expensive) medications must be used. [16]

Making sure everyone has access to medicine is critical for public health. Shortages can delay treatment and worsen health outcomes, especially for vulnerable groups (children, elderly, people with chronic diseases, …). [16]

The pharmaceutical industry has a large environmental footprint. This includes greenhouse gas emissions, high energy and water use during manufacturing, chemical waste, and packaging waste (mostly plastics). Pharma contributes significant CO₂ emissions and environmental pollution(like water contamination and emissions) if not managed responsibly. "Research suggests that the pharmaceutical industry generates approximately 52 megatons of CO₂ annually, equivalent to the emissions produced by 11 million cars in a year. " [17]

Environmental issues can increase costs(e.g., investing in green tech). Regulatory pressure and investor focus on sustainability means companies have to change their ways. Also, Public and consumer expectations push companies to be more transparent about sustainability. [18]

The industries impact on ecosystems has consequences for both public health and the environment. Meeting global climate goals and reducing waste protects natural resources and aligns with societal expectations for responsible business. [17]

Health Canada has a shortage reporting and mitigation plan [16]. Producers must report shortages and policymakers are planning to require safety stocks for critical drugs. Health Canada works with suppliers and healthcare partners to identify alternatives and reduce impacts when shortages occur. There is also a Multi-Stakeholder Steering committee that works on shortage prevention and policy [19].

• You can talk to your healthcare provider early when prescriptions run low to plan alternatives.
• Avoid stockpiling medicine, because that worsens shortages.
• You can report shortages to pharmacies or national reporting systems to help data tracking.

Renewable energy, safer chemicals, and recycling practices are used in manufacturing and chemistry to reduce waste and emissions. Shifting to recyclable or biodegradable materials and reducing excess plastic in packaging can also help. Furthermore, pharmaceutical supply chains are adopting: transportation emissions are being reduced and supply routes are shortened. This reduces emissions. [20]

• Properly disposing of unused medications avoids environmental contamination.
• You can support companies with strong environmental policies and ask pharmacies about sustainable choices.
• it is important to reuse or recycle packaging when safe and possible.