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Finding Your Pathway Into Regulatory

Posted 06 September 2012 | By Zachary Brousseau 

How can I get started in regulatory? This question comes up quite often. Interest in getting into the healthcare products regulatory profession is growing among professionals in related fields such as research and development, quality and laboratory sciences. At the Regulatory Affairs Professionals Society (RAPS), we get this question in emails and phone calls, and hear it asked at conferences and networking events, and voiced in multiple social media conversations and online forums.

With increasingly complex regulations and often multiple regulatory authorities involved in global supply, distribution and marketing efforts, the need to ensure healthcare products meet regulatory requirements has never been more critical, and the cost of failing to do so has never been higher.

Even as other areas of the healthcare products and life science sectors have been subject to hiring freezes or staffing cutbacks, qualified regulatory professionals continue to be in high demand, as attested to by the results of the recently released 2012 Scope of Practice and Compensation Report for the Regulatory Profession from RAPS. Average salaries are continuing to rise as companies seek to attract top regulatory talent. In addition, the importance and diversity of regulatory work are significant factors in drawing many professionals, particularly those with science backgrounds, to regulatory careers.

Getting Your Foot in the Door

With this heightened interest in the regulatory field in mind, RAPS recently hosted a free webcast, Strategies for Your Career: Finding Your Pathway Into Regulatory, to help those interested in entering the regulatory profession get a better understanding of how to make the transition and get some advice on presenting themselves to potential employers.

Erica Arkin, a pharmaceutical and biotech search consultant and recruiter with Clockwork Consulting, and Cindy Phillips, senior director of regulatory global labeling and promotion for Millennium Pharmaceuticals Inc., were the featured presenters, and also spoke with Regulatory Focus individually about the pathway to a regulatory career.

"Getting into regulatory is difficult," Arkin said candidly during the webcast. Developing and getting a medical or healthcare product approved is a significant investment-"anywhere from $55 million to $2 billion." Mistakes can be costly and companies want their regulatory teams to be able to see products through the process with few surprises or complications.

However, that does not mean that it is impossible to get a foot in the door in regulatory. Arkin advises job candidates to be able to tell their stories about why they are prepared to make the switch to regulatory, and to be able to demonstrate their commitment to the field. She says that getting involved in organizations such as RAPS or pursuing regulatory postgraduate education can be helpful in demonstrating that commitment.

She also underscored the importance of gaining experience in a related area, what she called "side entrances into regulatory." Quality and clinical backgrounds are very often helpful in getting relevant and desired experience, and in larger organizations, being able to work on regulatory projects as part of multidisciplinary teams may offer good opportunities to get real regulatory experience.

Varied Background Can be an Asset

Phillips emphasized the importance of attitude and commitment, as well. "Don't be off put just because you may not have what you consider to be an ideal background. If you have a passion for this and you really want to join regulatory, go for it," she said during the webcast.

Phillips, herself, came to regulatory without a science background, and explained to Regulatory Focus that skills such as interpersonal communication and project management are key attributes when working in regulatory. Speaking about the candidates she considers hiring, she said, "they have to have the intelligence and creativity, but mostly I want to see how they work with people. A lot of regulatory is working with people-at health authorities, etc."

"If you're willing to accept an entry level position as an associate, there are a lot of different things you can do to get your feet wet and show what you can do," said Phillips.

Both Arkin and Phillips pointed to contract regulatory work as a possible way to get into the profession, as companies, particularly mid-sized ones, often bring on contract workers.

Anyone may access the entire recorded webcast, Strategies for Your Career: Finding Your Pathway Into Regulatory, free of charge on-demand from the RAPS Store, and RAPS members also can find it archived in the member-exclusive RAPS Media Library online.

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