by Gord H. » Sun May 14, 2017 10:10 pm
I'll provide my perspective. I'm currently in a senior RA role at a large global pharma company. RA has evolved and has become more than just administrative work. There are 2 tracks in RA, RA operations and RA strategy. In my role I oversee a global RA team which includes RA operations and RA strategy colleagues.
RA operations roles focus primarily on the administrative aspect of the function and includes many of the things you described as well as tracking, managing and making submissions to health authorities. Because of the administrative nature of this work a life science degree is not necessary. Most of my RA operations colleagues do not have science degrees.
At a high level, RA strategy roles are leadership roles on matrix drug development teams which focus primarily on devising and implementing a plan to achieve a drug's target product profile. To be successful in an RA strategy role you need to have a good understanding of all aspects of drug development (clinical, clin pharm, non-clinical, stats, some CMC, etc) as well as key regulations, guidelines and policy. This is critical to be able to identify pathways to regulatory success (for instance IND clearance, expedited development pathways, NDA/BLA acceptance and approval, etc) and lead drug development teams to overcome hurdles or barriers to regulatory success. Also a big part of an RA strategy role is being the lead for FDA/health authority interaction. Consider that health authorities make decisions based on their evaluation of data that's generated from scientific, non-clinical and clinical studies, it would be difficult to be a successful regulatory strategist without a good understanding of the science. This is why it is useful to have a science background/degree, and in many cases senior regulatory strategy folks have advanced science degrees.
So back to your question, whether it's strategy or operations you're interested in the best way to break in is to network. Considering what you said about your interests and abilities I think it would be easier to break into an operations role. For such roles as long as you can demonstrate you're detail oriented, organized, and knowledgeable of MS software and publishing software you meet 70% of requirements for an entry level role. From my experience the internal industry folks transitioning into RA are not going into operations. They tend to be going into strategy so you should not have much internal competition if it's operations you're interested in.