Regulatory Affairs Q&A (Part 2)

Introduction

There are a number of career and learning opportunities available within the niches of regulatory affairs. However, unless you work at a smaller company where you ‘wear multiple hats’, then you will likely only specialize in one segment of regulatory affairs. Expanding my breadth of experiences across (and outside of) regulatory affairs was one of my main drivers in moving to a smaller company.

As a follow-up to “Regulatory Affairs Q&A (Part 1)”, I provide my thoughts on some of the other niches in regulatory affairs involved in the development and commercialization of medicines.

Chemistry, Manufacturing, and Controls (CMC)

Individuals who have a manufacturing or quality background may find CMC regulatory affairs enjoyable. Individuals who work in CMC regulatory affairs deal with the information and regulations that assure product safety, identity, quality, purity, and strength (including potency) of the medicinal product manufactured. CMC is applicable as early as candidate selection of your future product and work continues even after the approval of your medicine by regulatory authorities.

CMC regulatory affairs representatives work cross-functionally but primarily collaborate with the members of the manufacturing and quality teams. Like their clinical counterparts, projects may include, but are not limited to: submissions to health authorities, authoring of CMC related documents, interactions with health authorities, and development of strategies to ensure compliance with CMC laws and regulations.

Growing one’s knowledge of CMC regulatory affairs may also be important for individuals who plan on dealing with novel technologies such as cellular therapies. The work of CMC regulatory affairs professionals and their contributions to ensuring the quality of manufactured medicinal products is critical to a company’s success and to patients.

Labeling

Regulatory affairs with a focus on labeling is an interesting opportunity for pharmacists to consider due to their academic training, skill set, and familiarity with prescriber and patient labeling.

Professionals who focus on regulatory labeling are responsible for providing strategic and operational leadership in the area of product labeling for marketed and investigational products. Examples of projects focused on regulatory labeling can include supporting a drug or biologic’s development program (i.e. development of core data sheets and target product labels) or supporting approval of a medicine and its commercial launch (i.e. development of the professional and patient product labeling).

I think the most vital example of regulatory labeling is the country approved product label granted by the country’s regulatory body that oversees medicines. An approved product label is the result of a successful drug or biologic development program that communicates the key information about that approved medicine. This labeling is referenced by health care professionals on how the medicine should be used, provides detailed information for patients, and shows the medicine’s competitive advantages (or disadvantages) over competitors.

Advertising and Promotion (Ad Promo)

Of all the niches in regulatory affairs, I think ad promo requires the most creativity. As the ad promo regulatory representative, your goal is to help your company’s commercialized medicine’s competitive positioning while maintaining compliance with applicable FDA regulations for the advertising and promotion of prescription drugs and biologics. You will be providing your regulatory leadership and guidance to commercial teams during the development, review and approval of product labeling and advertising materials. The materials you review can include anything from advertisements, commercials, websites, and even Facebook pages and Facebook posts!

To be successful in ad promo, you have to find the right balance of compliance and creativity to ensure your commercial message is fully communicated but prevents any type of warning letters from the FDA in the future. Failure to comply with warning letters can result in steep fines, product seizures, or even criminal prosecution. The work of ad promo professionals plays a key role in a medicine’s commercial launch since a weak commercial strategy will negatively impact a company’s bottom line.

Lastly, If you are an individual who wants to be closer to the commercial side in a pharmaceutical/biotechnology company, then building your regulatory career in regulatory affairs may be for you.

Regulatory Operations and Publishers

If the regulatory affairs group was a peanut butter and jelly sandwich, then the members of regulatory operations and regulatory publishing (collectively abbreviated here as RegOps) are the pieces of bread that hold the regulatory department sandwich together. The members of the RegOps group are the often unsung heroes in a team and regulatory organization, yet their role is vital to a regulatory groups’ and company’s success.

RegOps primarily work directly with their regulatory affairs colleagues. However, RegOps can work with other departments to share their technical expertise on regulatory systems management or regulatory submissions themselves. RegOps responsibilities can include managing the regulatory affairs related systems, work in project teams to provide technical guidance to ensure successful regulatory submissions, and are the sole party that completes the actual regulatory submission itself.

It takes a tremendous amount of time to appropriately manage a regulatory database. Furthermore, regulatory submissions are complex. It takes time to prepare both a regulatory submission and the documents (some of which may be hundreds of pages in length) to be included within said regulatory submission. Regulatory submissions are an official means of communications with regulatory authorities, so good luck trying to file that marketing application and get your medicine to patients without RegOps support.

Though not required, regulatory affairs professional would be wise to understand and learn some of the technical nuances required of regulatory submissions and regulatory systems. This is especially important if you work for a smaller company without a dedicated RegOps group.

Conclusion

The work in regulatory affairs is more heterogenous than people realize, and all the discussed subsets of regulatory affairs play an important role in getting new medicines to patients. Whether or not one specializes in any of these regulatory affairs niches, I believe gaining knowledge of these different regulatory affairs subsets is important. Broad knowledge of these different regulatory affairs opportunities betters an individual as professional and may help if one has plans to one day lead a regulatory department.

In future posts, I plan to do deep dives on the regulatory affairs niches discussed in this post (and some I did not discuss) through Q&A sessions with individuals who currently work in them. Stay tuned and thank you again for reading!

Author’s Note

I welcome your comments and questions to build on this discussion to further raise awareness of the opportunities in regulatory affairs to help individuals interested in the profession.

Additionally, if you are interested in getting into regulatory affairs and think I can be of service to you, then please send me a note!