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  • 1.  Development Plan

    This message was posted by a user wishing to remain anonymous
    Posted 04-Nov-2020 09:23
    This message was posted by a user wishing to remain anonymous

    Hello,

    I would like to know if anyone has sat down and created a development plan with their manager or would be willing to share a sample development plan that they had created for their own path for growth. Currently, I am a regulatory affairs associate and would like some ideas or focus areas that I should focus on in order to progress toward a senior associate role.

    Thanks in advance.



  • 2.  RE: Development Plan

    Posted 04-Nov-2020 14:39
    Hi,

    When I managed RA professionals, we had development plans that were specific to each person and the company's needs.  My director also had a list of RA skills; however, I don't have that list (it would be great to provided if I did!).  I suggest you meet with your manager and determine what knowledge, skills and experiences would be beneficial for your specific company and develop a plan for you to get training or experience in those areas.  There is such a wide variety of skills associated with RA professionals that I think you need to decide your interests, your company's needs and then develop a plan specifically for you.

    I hope others on the RegEx Forum have a development template that they are able to provide.  The templates I previously used were for my former company's performance appraisals (confidential).  Below are some topic ideas for brainstorming related skills & experience (i.e. Professional Interests) and general categories from my previous company's performance appraisals (~2014). 

    Professional Interests:
    a. Advertising, Promotion and Labeling
    b. Audit/FDA Inspection
    c. Clinical Trials
    d. Chemistry, Manufacturing and Controls (CMC)
    e. Compliance
    f. Environmental
    g. Ethics
    h. FDA meeting and communication strategy
    i. Preclinical study
    j. Product Lifecycle
    k. Professional Development/Training
    l. Project management
    m. Quality Assurance and Control
    n. Regulatory Intelligence/Policy
    o. Research, Design & Development
    p. Supply Chain Management
    >>>I would add "Registration" (i.e. regulatory approval, clearance, licensing, etc.)
    >>>You could also look into regions of interest (e.g. US, Europe, Canada, Asia, etc.)

    Performance Appraisal General Info:
    • Company's Mission
    • Performance Ratings
    • Employees Input on Performance Goals (i.e. self evaluation)
    • Skills Development Info (training, certification, continued learning)
    • Teamwork / Leadership
    • Questions  (e.g. ideas for creating value for the company, job activities you are passionate about, growth opportunities, professional goals, etc.)

    I hope this gives you some ideas and provides initiative for others to reply with their input.  Feel free to reach out if you would like to chat via phone. 

    Kind regards, 


    ------------------------------
    Alyssa Thomas RAC
    Principal Consultant
    Beaverton OR
    United States
    ------------------------------

    Original Message


  • 3.  RE: Development Plan

    Posted 17-Nov-2020 19:22
    Edited by Annie Chang 17-Nov-2020 19:23
    Thanks, this list is very helpful.
    ------------------------------

    Original Message


  • 4.  RE: Development Plan

    Posted 05-Nov-2020 08:05
    Hi Anon.

    I could not agree more with one specific point that Alyssa made - development plans are best when they are specific to an individual.  Think about it logically - you don't have the same experience or knowledge as anyone else probably in the world - not just your organization.  Lots of what you need to know or get experience in doing is very much based on your own aspirations.  Do you want to concentrate on drugs, biologics, devices, tobacco, or cosmetics?  What classification/category/indication areas are you interested in?  Is the company currently in need of someone with that skill set?  Does the company have someone with the skills that you are interested in learning/broadening who you could work with?  Are there any special projects or early development opportunities for you to gain additional experience or knowledge and understanding that your company is in need of additional regulatory support?  Are you looking to become a "subject matter expert" or are you looking to lead people as your career progresses?  All of these are questions that you need to ask yourself and some of them can be discussed with your manager to see if they know of anything.

    I understand all too well what it is like to be in a junior position in a company and not having specific information about what is happening currently that you could potentially use for further development opportunity.  That is where your discussion with your manager and their discussion with their leadership comes in hopefully to help you get a little more clarity.  But I firmly believe that you have to come to the table with at least an idea of your own interests and to also have an understanding of your own blind-spots with regard to what you know, what you think you know and what you know you don't know (better known as a level of self-awareness).  This should help you guide your own learning and career development as well as showing the manager and management more generally what you are interested in and the path you are interested in taking in your career.

    ------------------------------
    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
    ------------------------------

    Original Message


  • 5.  RE: Development Plan

    This message was posted by a user wishing to remain anonymous
    Posted 05-Nov-2020 09:26
    This message was posted by a user wishing to remain anonymous

    I would ask a question - on your projects, what are the areas where you wished you knew more, and where you saw other people and wished you had those skills?

    Next, I don't know that I can provide a career plan, but I'd recommend trying to understand, what you don't know that you don't know, and that will help you identify skills you want to grow in. I collect articles on professional development, and below are ones that may help you consider areas that you want to grow in related to regulatory topics:

    https://www.raps.org/news-and-articles/news-articles/2020/2/why-understanding-regulatory-affairs-is-important?feed=Regulatory-Focus
     
    http://www.raps.org/Regulatory-Focus/Features/2017/07/17/28091/Regulatory-Career-Progression/
     
     
    https://www.raps.org/regulatory-focus/news-articles/2019/8/transitioning-between-medical-writing-and-regulatory-affairs-in-a-contract-research-organization?feed=Regulatory-Focus
     
    https://www.raps.org/news-and-articles/news-articles/2020/2/the-changing-role-of-the-regulatory-professional?feed=Regulatory-Focus
     
    https://bemycareercoach.com/soft-skills/list-of-the-most-important-communication-skills.html
     
    https://www.greenlight.guru/blog/career-tips-quality-regulatory-medical-device-industry
     
    https://www.raps.org/news-and-articles/news-articles/2019/3/focus-on-minnie-baylor-henry?feed=Regulatory-Focus
     
    https://www.raps.org/news-and-articles/news-articles/2020/2/demonstrating-regulatory-value?feed=Regulatory-Focus
     
    https://www.scienceofpeople.com/people-skills/
     
    http://www.quickanddirtytips.com/productivity/organization/how-set-unplannable-goals?page=all
     
    https://hbr.org/2017/10/simple-ways-to-spot-unknown-unknowns
     
    https://askleo.com/are-human-relations-skills-important-in-tech/


    Original Message


  • 6.  RE: Development Plan

    Posted 05-Nov-2020 10:40
      |   view attached
    Hi there,

    Great tips provided by folks so far.

    I've attached a regulatory competency framework that RAPS released a couple of years ago. Like you, I was seeking to create my own development plan. This framework splits regulatory competency into four levels by regulatory skill. I used this as a checklist for myself to assess where I stood for each regulatory skill. Once I had identified my levels, I identified the levels I wanted to reach and noted which areas I wanted to develop in. Then I sought out opportunities to further my knowledge and application in those particular areas e.g. webinars, conferences, "stretch" projects in which I could grow my skills, reading lists to further regulation knowledge.

    Hope this helps you create your development plan. It's great that you're taking the initiative, because you will always be your biggest advocate. Good luck!

    ------------------------------
    Hiral Dutia
    Sr. Regulatory Affairs Specialist
    Third Pole Therapeutics
    Waltham, MA
    USA
    ------------------------------

    Attachment(s)

    pdf
    RAPS Regulatory_Competency_Framework.pdf   833 KB 1 version
    Original Message


  • 7.  RE: Development Plan

    Posted 05-Nov-2020 15:22
    Agreed with Alyssa and Victor. Few additional comments are:

    1. Create an action plan for your short-term and long-term goals. Action plan can include both soft and technical skills (development needs from annual performance reviews and your own interests and strengths). Track and report progress on the action plan to your manager and ask for help as needed.
    2. Look for short term cross-functional "stretch/challenging projects" or assignments to get experience in your interest areas.
    3. Look for a mentor other than your manager.

    All the best.
    Meena

    ------------------------------
    Meena Garg
    Regulatory and QA Consultant, Vaccines
    Brampton ON
    Canada
    ------------------------------

    Original Message


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