What is the role of regulatory affairs in pharma industry?

The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.

Are regulatory affairs easy?

Regulatory affairs can be a difficult field to break into, because many companies prefer to hire RA professionals from among their own employees. If you work for a company with an RA department, you can gain experience by shadowing some of your company’s existing RA professionals and receiving mentoring from them.

What are the roles and responsibilities of regulatory affairs?

The department of Regulatory Affairs is established to protect public health, by monitoring and controlling the safety and efficacy of drugs within several domains including pharmaceuticals, veterinary medicines, agrochemicals, cosmetics, medical devices, pesticides, and complementary medicines.

What are the goal of regulatory affairs professionals?

The goal of the regulatory affairs professional is the protection of human health, ensuring safety, efficacy, and quality of drugs, ensuring appropriateness and accuracy of product information.

Is quality assurance part of regulatory affairs?

Regulatory affairs professionals are concerned with ensuring that products comply with government regulations, while quality assurance professionals are focused on delivering high-quality products to consumers.

Why do you like regulatory affairs?

The field of regulatory affairs offers career stability and plenty of room for advancement. You’ll get to make a tangible difference by ensuring that the pharmaceuticals, medical devices, cosmetics, foods, and nutritional products that we all use are safe and effective.

How do you grow in regulatory affairs?

How can you progress your Regulatory Affairs Career?

1. Gain mentoring experience (senior-level positions)
2. Stakeholder management experience.
3. The Organisation for Professionals in Regulatory Affairs (TOPRA) certification.
4. Sandwich placements.

Is r&ca the key to quality assurance in pharmaceutical and biotechnology?

While the stakes for implementing R&CA solutions for pharmaceutical, biotechnology, and medical device quality assurance are high due to the impact on patient safety, other industries have overcome similar challenges. For example, the autopilot feature on virtually every modern airplane is an autonomous rules-based (RPA) program.

Are biotechs the future of Pharma?

Biotech companies could lead the charge in scientific and business model innovation and will be responsible for much of these shifts in pharma. And while consolidation of biotech by large pharma companies is likely to occur, a new class of biotech companies that rival large pharma will emerge.

Will the pharmaceutical industry reinvent itself in the future?

And while consolidation of biotech by large pharma companies is likely to occur, a new class of biotech companies that rival large pharma will emerge. I believe the pharmaceutical industry will reinvent itself and will play a significant role in improving the health of billions of people around the world.

Does large pharma still look to small biotechs for in-licensing drugs?

I’ve also seen large pharma look to small biotech companies for in-licensing drugs. According to the IQVIA Institue report, emerging biopharma companies “patented almost two-thirds of new drugs launched in 2018,” although large pharma stills plays an important role.