Industry

Regulatory Affairs: A Day in the Life Of.

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Interested in a career in regulatory affairs? Click through to find out more!

Written by /u/LifeAfterLifeScience and copied with permission

Communicating

At the most basic level, you act as a trader in information. You’ll stand at the midpoint between a vast variety of departments, experts and regulators – and you’ll be keeping information flowing between each and every one of them. Emails, reports, meetings, phone calls, the job involves keeping people up to date and in the loop. Communication lies at the heart of regulatory affairs, so expect to do a lot of it.

Organising

Are you organised? You’d better be – you’ll be juggling multiple projects at any one time, plus various meetings and whatever emergency has come up this time. Being able to keep track of these requirements is a must. You’ll need to be able to plan both in the short term (today’s chaos) and the long term (what is our 4 year development plan?). This is where the typical scientific background, with its multitasking of experiments, writing, and meetings, really comes in handy.

Managing

The job title is Regulatory Affairs Manager, and so it’s fairly clear that there’s management involved. But it’s not ‘management’ in the sense of having people reporting to you and doing the tasks you assign them (well, not until later at least). Instead it’s managing people without actually having any formal authority over them – you can’t give orders, you’ll have to persuade, wheedle, nag, bargain, compromise and trade your way to your goals. This is not to say that people won’t want to help you, but each expert you approach will have a ridiculous number of demands on their time. Why should they help you? You need to be persuasive, and this is why interpersonal skills are one of the main talents HR looks for when hiring.

Writing dossier modules

Want approval to market your miracle drug? First you need to show that you know what you’re doing – that your product is safe, effective, and made in a (consistently) high-quality way. This is done via the dossier, a vast document split into numerous sections covering every stage of the development process and the future plans. As you’d expect, working on a product’s dossier takes up a lot of time. Whether it’s putting together the initial application or making updates to a previously-approved one, a regulatory career will revolve around the dossier.

Working with source documents

This is a pretty big change for people coming in from academia or research: you’re done with laboratory work. Others within the company will be doing protein analysis, clinical studies, purity checks – that’s not your job any more. Instead, you’ll take the work produced by these people (studies and reports), and use that as a basis for their own writing. You still need experience dealing with scientific data and methods (to understand what you are reading!), but the data is produced by others. Your job is to understand these source documents so that you can decide how much of it ends up in the dossier.

Providing regulatory advice

You aren’t just reading reports and writing dossiers. Because companies are always changing their methods (trying to optimise for cost and yield), you’ll be part of the change evaluation process – saying how much regulatory stress is involved in any given change. That clever idea to increase yields by a few percent is less worthwhile when the FDA demands several years of stability data first. Likewise, your advice will be needed to plan these changes. What will be needed to get approval for your drug? What kind of studies will be needed in the final submission? This is where regulatory affairs comes in.

Thoughts on transitioning into reg. affairs straight from the bench?
It depends on the company. Small biotechs will likely be looking for candidates with more experience however large pharma companies often hire people straight out of a PhD or postdoc and train them up.  

Kind of interesting?

If this sounds like your area and you want to know more, then either drop me a question here or check out our short guide for life scientists on Amazon. Or both 😀

Job Listing: Client Support Specialist – Boston, Promega

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Client Support Specialist – Boston

 Job Description:

JOB OBJECTIVE:        The Client Support Specialist will serve as the liaison to our internal and external customers.  Provide technical support and information about Promega products and services, thereby building strong customer relationships that will lead to an increase in information exchange, technology acquisition, and economic interaction.  Responsible for coordination of all end user-defined activities in their respective territories, including assisting distributors.
All times are in Eastern Daylight Time.

Job ID 
2016-1284
# of Openings 
1

Posted Date 
4/13/2016
Category 
Sales

Location : City 
Virtual

More information about this job (click here):

ESSENTIAL DUTIES:
  1. Use Sales Analysis and designated CRM to generate reports, manipulate data and effectively analyze results.  Maintain appropriate notes in the designated CRM.
  1. Identify and maintain strategic accounts and clients to maximize effectiveness.  Consistently request, receive and leverage customer referrals.
  1. Develop and maintain an active sales funnel of opportunities across the Promega product portfolio.
  1. Provide technical support by thorough knowledge of Promega’s product line and effective communication of applications related to the products.
  1. Support and develop strong customer and distributor relationships by acting as a liaison between the customer and various departments at Promega.  Bring field issues and complex sales opportunities to the regional manager and provide necessary customer follow up.  Identify both new technologies/products and “targeted” technologies/products that will benefit Promega’s business efforts.
  1. In cooperation with the Regional Manager, design and implement a coordinated business plan for the territory that reflects Promega’s corporate initiatives while taking into consideration the customer situation (funding, technology needs, etc)
  1. Work with the regional manager to develop opportunity based pricing strategies at accounts (quotes, purchasing contracts with discount schedules, freezer programs and stockroom/consignment).  In conjunction with the Promega business units, organize and conduct field-marketing activities such as workshops, focus groups and beta test programs to gain customer feedback.
  1. Remain familiar with competitive products for the purpose of educating customers on the benefit of Promega technology.  Monitor the competition  and report important activites (technical developments, trends within key accounts, seminars, training sessions, etc) back to Promega.
  1. Drive awareness and success of the Helix program through Helix stocking and sample follow up.  Host Helix relaunch parties, develop stock customization, work with the SBU to appropriately market the unit within the account.
  1. Work with SBU resource/Inside Sales Team/CAM to provide instrument demonstrations with the goal of moving opportunities forward.
  1. Discuss relevant market investment activities and playbook items for strategic territory development with the regional manager on a regular basis and enact plans to achieve goals as defined in conjunction with the regional manager.  Succinctly deliver account and territory plan presentations to the sales team at regional meetings.
  1. Flexible in handling change, meeting a standard of excellence, persistent in pursuing goals despite obstacles and setbacks.  Self-awareness of how behaviors can affect our colleagues.
  1. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
OCCASIONAL DUTIES:
  1. Attend Sales Training sessions for Miller Heiman and Spin Selling.  Independently develop SPIN call plans and identify appropriate use.  With manager assistance fill out and review Blue/Green sheets and sales call plans.
  1. Represent Promega at conferences, shows, workshops and seminars locally, regionally or nationally, as necessary.  Organize and plan lectures, vendor shows, workshops and seminars in specific territory.
  1. Participate in organization for regional and national sales meetings including logistics, food, etc.
MANDATORY QUALIFICATIONS:
  1. BS or BA (MS, or Ph.D. preferred) degree in a life sciences related discipline.
  1. Technical competency to understand and to clearly discuss fundamental theory and principles of experimental design, techniques and results; to stay current in technical knowledge; to troubleshoot and to provide information back to the customer in a helpful, courteous, positive and professional manner.
  1. Minimum of 2 years lab experience with proven knowledge and understanding of molecular biology, cell biology and related fields.

How to Design a Drug: Insights into Drug Discovery

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Drug

Today we are joined by Sarah Dykstra, PhD, who worked in the early drug discovery group at Amgen. Many of our postdocs and PhD students will end up in R&D, so its a great opportunity to learn about your potential future career.

Big thank you to Thermo Fisher Scientific for sponsoring this seminar! Remember that if you need any support from Thermo Fisher, feel free to reach out to our Account Manager, Adam!

Here are some insights from the seminar on the drug discovery pipeline:
(A copy of the slides can be found at the end of the post!).

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How to Develop a Great Research Idea

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We were joined by David R. Walt, PhD, the Robinson Professor of Chemistry and HHMI investigator on how to develop your next big scientific idea for success in Academia and Industry. Here are a few highlights from the talk:

Idea
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