Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I have 17 years of RA experience and have been a senior manager for 2 years. I report to the head of the RA/QA, who joined the company before I did. He had retired at 60, but was called back by the CEO to support our regulatory submission (PMA) to FDA. He continues to be the liaison between the company and FDA, I have asked him to train and let me do the talking but he is not able to let that go. My boss has a sea of knowledge but since he had retired (tail end of his career), I do not see him taking any active interest in my career. We do not talk about anything but projects. I am not learning new skills, I am simply completing tasks which are tactical in nature. 

I would like to know from the RAPS community what skills are needed to move up the ladder to my next position and how should I acquire them? Kindly share from your experience what domain should I concentrate on (financial budgeting, clinical, R&D, negotiation, etc.)? I realize that I am in charge of my career, so instead of relying on my manager, I want to take active interest and develop the necessary skills. 

Hello Anon,

Thanks for sharing your situation and maybe dilemma.  I guess the first comment, if you have not done already, is have a frank and straight-forward discussion with this Head of QA/RA/Consultant about you needs, requests, support, and guidance.  Without knowing this person, hopefully they can respond positively to your request and help provide guidance beyond as you say the tactical part of a position.  Someone at tail end of career should recognise the need to "pass it forward".  Which what you are looking for is a good mentor who can guide in the all "in between" items of quality and regulatory.  A person can read a regulation, look at a standard, or go through a guidance document, but there can be so many between the lines which often are gained through experience.  Then as you said there are the other skills like people interactions, teams, dealing with peers, financials, and time management on projects.

Luckily early in my career I has some good mentors and also having a few years under my belt, I really appreciated having the guidance, skills development, understanding concepts, and even an unbiased person to vent to for advice.  With availability of networking and such today, from a quality/regulatory perspective you can find some helpful people to mentor or get helpful advice through forums like this, local groups, or even just building a professional relationship with people who want to help.  For the other type of skills, honestly you do not need a quality/regulatory person - things like dealing with people or budgets - can be helpful finding someone who can help guide and direct you.  A couple of mentors had nothing in quality and regulatory, in fact, they could not really help in regulatory.  However, they helped me understanding budgeting (which I loathed), building great presentations, delivering good presentations, or dealing with management persons who you have 30 seconds to get your point across.

This also is not necessarily from one person, but you could have 2 or 3 people sharing in different aspects of your growth.  It can be challenging these days because everyone is so busy and finding time to sit down for 15 or 30 minutes can be a challenge in itself.  I can only share what you should concentrate on really depends on what you want to do.  If you want to move from manager, to director, to VP, maybe all of those skills and experience are needed.  If you want to concentrate on being a director in regulatory only dealing with submission type work, then communication, dealing with regulatory agencies, and different experiences with filing submissions might be more helpful.  Good luck and indeed you are in charge of your career !

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 15-Mar-2024 13:14
From: Anonymous Member
Subject: Career advice (Transitioning from Sr. RA Manager to RA Director)

This message was posted by a user wishing to remain anonymous

I have 17 years of RA experience and have been a senior manager for 2 years. I report to the head of the RA/QA, who joined the company before I did. He had retired at 60, but was called back by the CEO to support our regulatory submission (PMA) to FDA. He continues to be the liaison between the company and FDA, I have asked him to train and let me do the talking but he is not able to let that go. My boss has a sea of knowledge but since he had retired (tail end of his career), I do not see him taking any active interest in my career. We do not talk about anything but projects. I am not learning new skills, I am simply completing tasks which are tactical in nature. 

I would like to know from the RAPS community what skills are needed to move up the ladder to my next position and how should I acquire them? Kindly share from your experience what domain should I concentrate on (financial budgeting, clinical, R&D, negotiation, etc.)? I realize that I am in charge of my career, so instead of relying on my manager, I want to take active interest and develop the necessary skills. 

This message was posted by a user wishing to remain anonymous

Strongly recommend you take a look at the RF Quarterly October 2023 (https://www.raps.org/News-and-Articles/News-Articles/2023/9/RF-Quarterly,-September-2023-Leadership-in-regulat?feed=Regulatory-Focus) and the September 2022 issues (https://www.raps.org/news-and-articles/news-articles/2022/9/introduction-regulatory-strategy)

Also, take a look at this tool released by RAPS:
"RAPS releases framework addendum and assessment tool for regulatory professionals"

https://www.raps.org/news-and-articles/news-articles/2023/1/raps-releases-framework-addendum-and-assessment-to?feed=Regulatory-Focus

Original Message:
Sent: 15-Mar-2024 13:14
From: Anonymous Member
Subject: Career advice (Transitioning from Sr. RA Manager to RA Director)

This message was posted by a user wishing to remain anonymous

I have 17 years of RA experience and have been a senior manager for 2 years. I report to the head of the RA/QA, who joined the company before I did. He had retired at 60, but was called back by the CEO to support our regulatory submission (PMA) to FDA. He continues to be the liaison between the company and FDA, I have asked him to train and let me do the talking but he is not able to let that go. My boss has a sea of knowledge but since he had retired (tail end of his career), I do not see him taking any active interest in my career. We do not talk about anything but projects. I am not learning new skills, I am simply completing tasks which are tactical in nature. 

I would like to know from the RAPS community what skills are needed to move up the ladder to my next position and how should I acquire them? Kindly share from your experience what domain should I concentrate on (financial budgeting, clinical, R&D, negotiation, etc.)? I realize that I am in charge of my career, so instead of relying on my manager, I want to take active interest and develop the necessary skills. 

Hi Anon,

I'd like to add to the great advice already provided. If you have not done so already, I recommend first spending time getting very clear with yourself about what you want out of your career. Actually, back up even further and determine what life you want and how your career fits in. I have made several transitions in my career over the last 30 years including working remotely when I moved to another state over 20 years ago, working part time in a company that historically denied these requests, and leaving corporate to work independently. I found that clarity about myself, my must-haves and my nice-to-haves, made negotiating these transitions not only successful, but as smooth and easy as possible. 

I was in a similar situation to yours for years, and having more to offer than what I was allowed to contribute really took a toll on my self-confidence. Here is what worked for me for moving on. 

I spent time evaluating my values and priorities, talents, skills and gaps. There are many resources out there for this, and I have read so many of them that many started sounding alike. I was focused on people leadership so I landed on using Clifton StrengthsFinder (Gallup) and Radical Candor by Kim Scott as a baseline, but find resources that resonate for you. In parallel, and most informative, was scheduling time with current and former colleagues and requesting honest feedback. These conversations helped me to develop a network of mentors with different perspectives, something Richard has already recommended. Taking time to sift through all these inputs to develop a clear picture of who I am and what I wanted next was invaluable. This foundation made developing a plan to achieve the next step and communicating my goals so much easier.

Feel free to DM me.

Best of luck!

------------------------------
Marianne Jacklyn
Principal Consultant
West Linn OR
United States
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Original Message:
Sent: 15-Mar-2024 13:14
From: Anonymous Member
Subject: Career advice (Transitioning from Sr. RA Manager to RA Director)

This message was posted by a user wishing to remain anonymous

I have 17 years of RA experience and have been a senior manager for 2 years. I report to the head of the RA/QA, who joined the company before I did. He had retired at 60, but was called back by the CEO to support our regulatory submission (PMA) to FDA. He continues to be the liaison between the company and FDA, I have asked him to train and let me do the talking but he is not able to let that go. My boss has a sea of knowledge but since he had retired (tail end of his career), I do not see him taking any active interest in my career. We do not talk about anything but projects. I am not learning new skills, I am simply completing tasks which are tactical in nature. 

I would like to know from the RAPS community what skills are needed to move up the ladder to my next position and how should I acquire them? Kindly share from your experience what domain should I concentrate on (financial budgeting, clinical, R&D, negotiation, etc.)? I realize that I am in charge of my career, so instead of relying on my manager, I want to take active interest and develop the necessary skills. 

Hi Anon, Thank you for sharing your situation. From what I have seen as you make the jump to the next level soft skills become more important. Things like Strategy, negotiation, business acumen and talent management and development are some of the skills I can recommend developing. I am glad that you're taking things things in your hand. Below are some of my recommendations to get started. Hope you find them useful.

Strategy- This book "Thinking strategically" by Avinash Dixit helped a lot. 

Regulatory Strategy- Global Pharmaceutical and biologics Regulatory strategy (Available on RAPS)

Negotiation- Book called "Never split the difference" by Chris Voss

Business acumen- "Business foundations" course on Coursera gives you a great introduction to Business in general. 

Talent management- Read "Radical candor" by Kim Scott.

All the best.

------------------------------
Mehul Govani RAC
Regulatory Affairs Manager
PL Developments
Westbury NY
United States
------------------------------

Original Message:
Sent: 15-Mar-2024 13:14
From: Anonymous Member
Subject: Career advice (Transitioning from Sr. RA Manager to RA Director)

This message was posted by a user wishing to remain anonymous

I have 17 years of RA experience and have been a senior manager for 2 years. I report to the head of the RA/QA, who joined the company before I did. He had retired at 60, but was called back by the CEO to support our regulatory submission (PMA) to FDA. He continues to be the liaison between the company and FDA, I have asked him to train and let me do the talking but he is not able to let that go. My boss has a sea of knowledge but since he had retired (tail end of his career), I do not see him taking any active interest in my career. We do not talk about anything but projects. I am not learning new skills, I am simply completing tasks which are tactical in nature. 

I would like to know from the RAPS community what skills are needed to move up the ladder to my next position and how should I acquire them? Kindly share from your experience what domain should I concentrate on (financial budgeting, clinical, R&D, negotiation, etc.)? I realize that I am in charge of my career, so instead of relying on my manager, I want to take active interest and develop the necessary skills. 

This message was posted by a user wishing to remain anonymous

Please don't focus on title! First, self assess what type of regulatory work you like doing or what type fits with your personality.

Simply put, there are 3 major types of RA: 1) Strategic 2) Compliance or Post approval type and 3)  Operational

Strategic: Mostly in development space but also exists in post approval Indication development approval e.g. Can you provide regulatory perspective on any of the contributory functions like nonclinical, clinical, CMC enabling transitions from pre-IND to Phase 1 or POC and to market approval/FDA liaisons/leading FDA meetings etc. 

Compliance type: Basically people who fit this category have liking towards adhering to the regulations/guidances CFRs etc. Thus post approval RA is a good fit. 

Operational: is publishing eCTD, regulations towards supporting clinical trials-1572 compliance, waivers, submissions/formats IND, NDA BLA etc, Modules etc....

Original Message:
Sent: 15-Mar-2024 13:14
From: Anonymous Member
Subject: Career advice (Transitioning from Sr. RA Manager to RA Director)

This message was posted by a user wishing to remain anonymous

I have 17 years of RA experience and have been a senior manager for 2 years. I report to the head of the RA/QA, who joined the company before I did. He had retired at 60, but was called back by the CEO to support our regulatory submission (PMA) to FDA. He continues to be the liaison between the company and FDA, I have asked him to train and let me do the talking but he is not able to let that go. My boss has a sea of knowledge but since he had retired (tail end of his career), I do not see him taking any active interest in my career. We do not talk about anything but projects. I am not learning new skills, I am simply completing tasks which are tactical in nature. 

I would like to know from the RAPS community what skills are needed to move up the ladder to my next position and how should I acquire them? Kindly share from your experience what domain should I concentrate on (financial budgeting, clinical, R&D, negotiation, etc.)? I realize that I am in charge of my career, so instead of relying on my manager, I want to take active interest and develop the necessary skills. 

Hi Anon, 

thanks for the question and I appreciate all the interesting answers to the question provided. I would add a recommendation regarding communication skills and highly recommend to join a toastmasters club nearby.  There is also a regulatory affairs toastmasters club meeting online which was also posted in one of the forum entries. 

------------------------------
Jella-Andrea Abraham
Regulatory Expert
Merck KGaA, Darmstadt, Germany - ENTERPRISE
Darmstadt
Germany
------------------------------

Original Message:
Sent: 15-Mar-2024 13:14
From: Anonymous Member
Subject: Career advice (Transitioning from Sr. RA Manager to RA Director)

This message was posted by a user wishing to remain anonymous

I have 17 years of RA experience and have been a senior manager for 2 years. I report to the head of the RA/QA, who joined the company before I did. He had retired at 60, but was called back by the CEO to support our regulatory submission (PMA) to FDA. He continues to be the liaison between the company and FDA, I have asked him to train and let me do the talking but he is not able to let that go. My boss has a sea of knowledge but since he had retired (tail end of his career), I do not see him taking any active interest in my career. We do not talk about anything but projects. I am not learning new skills, I am simply completing tasks which are tactical in nature. 

I would like to know from the RAPS community what skills are needed to move up the ladder to my next position and how should I acquire them? Kindly share from your experience what domain should I concentrate on (financial budgeting, clinical, R&D, negotiation, etc.)? I realize that I am in charge of my career, so instead of relying on my manager, I want to take active interest and develop the necessary skills.