How I Returned to Regulatory Affairs After a 10-Year Break

RAPSRAPS' Latest | 09 April 2019 |  By 

The decision whether or not to take a career break can be an agonizing one. You might be thinking about stepping away to raise a family, care for an ailing relative, take a sabbatical, because of redundancy or for a number of other reasons. Whatever the reason, many consider it to be professional suicide.

It doesn’t have to be. I was able to make a successful return to the world of regulatory affairs after a 10-year career break. That’s not to say it’s easy. There are many challenges you might face going back to work after a long absence, but there are steps you can take to regain your career. It may even be possible to negotiate terms that will help make it easier for you to be more successful when making your return.

Deciding to Take a Career Break

In 2004, I was a global regulatory affairs manager for a leading pharmaceutical company, 30 years old and an expectant mother. I had started my career as an associate regulatory manager and had worked my way up to project lead, managing a global team responsible for multiple, simultaneous Marketing Authorisation Application (MAA) submissions for the company’s biggest product It was a very exciting and challenging role, and I absolutely loved it.

I took the UK’s statutory maternity leave of 52 weeks, planning to return to work in August 2005. However, the three-hour commute would have meant putting my daughter into nursery for 10 hours a day, and I didn’t want that. I took a deep breath and decided to resign to take an indefinite career break so I could stay at home and raise my family.

Ready to Return to Work

Fast forward to September 2014—10 years and three children later—my youngest son had started going to nursery a few mornings per week, and I felt it was time to think about a return to work.

Returning to work after such a long break is a daunting prospect. It may be difficult to think of yourself as a professional person, and it’s easy to question yourself. Am I still employable? Has the industry moved on too much? Will I be able to do it again? How will I be seen by my peers? Are my skills out of date? Does the need for flexibility and a work-life balance make me less attractive to potential employers?

It’s not an easy path to navigate and there are many challenges to overcome, but I can tell you from personal experience that it is possible.

The regulatory profession is dynamic and things are always changing. New regulations come into force, new procedures are introduced and changes in technology move quickly. But the regulatory world is a small one. Highly motivated, experienced managers with solid scientific backgrounds, communication and analytical skills, attention to detail and project management experience will always be sought after.

Getting Back up to Speed

During my 10-year break, I had not kept up with the regulatory environment or latest regulations. I had simply devoted myself wholeheartedly to being a full-time mum. So the first thing I had to do was get myself back up to speed.

A simple way of finding out what is happening in the biopharma and medtech industries is to sign up for relevant newsletters, such as RAPS’ RF Today, and to read regulatory journals and publications, including Regulatory Focus. For the latest regulations in force and best practices, look on individual health authority websites to see what’s new.

You will need to be able to “talk industry” in any interviews even if you’re not technically an expert. So make sure you know about important regulations that may have been implemented since you left the field and understand their impact. For me, it was the Paediatric Regulation (2012), variations guideline (2008) and the revision to the Clinical Trial Directive (2014).

In addition, familiarize yourself with new legislation, regulatory procedures, timelines for procedures, content of applications, industry trends, the latest buzzwords and how technology and processes have evolved and what the practical implications are for doing your job.

Building Confidence

One of the biggest challenges you may face when returning to work is regaining confidence in your own skills and abilities. Don’t underestimate what you can offer an employer based on your past experience and other transferrable skills. I remember thinking ‘what kind of skills do I have now?’ But when I really sat down and analyzed everything I had done and could do, it was clear that I had a lot to offer a potential employer.

Spend some time taking inventory of your skills, including those you may have gained since being away from full-time work, and where your strengths lie. Being a self-motivator and team player, organization skills, working well under pressure, good communication skills, adaptability and confidence are all attractive traits to a potential employer.

Write down any recent achievements even if they’re not work-related. Have you been involved in active fundraising or done any other volunteer work? These experiences help show that you haven’t been idle during your career break.

It can be helpful to talk with former coworkers or previous employers about projects you worked on together to refresh your memory of past achievements. Getting other peoples’ perspectives on your strengths and significant contributions can give you a real confidence boost.

Consider taking a refresher course to boost your confidence. I did a proofreading course just to get my brain working in an analytical way again.

Get Your CV Ready

An up-to-date CV or resume is imperative. There are many resources and examples online regarding proper formatting, content and word choice. Make your CV concise and snappy. Use bullet points to emphasize your skills and experience. Make it stand out despite the gap.

Bringing my CV up to date was not difficult. I had hardly anything to add except my career break, some PTA fundraising activities and the proofreading course.


It is vital that you make yourself visible in a professional capacity and let the right people know that you are available for work again. Make sure your LinkedIn profile is up to date, and stay active on the site, connecting with colleagues and sharing relevant news and information.

Of course, LinkedIn isn’t the only way to connect. I emailed some of my old colleagues and met up for informal chats. This was not only brilliant for boosting my confidence, it also gave me opportunities to ask questions, learn more about important trends, hear views on the current state of regulatory and how things have changed, and get potential job leads.

Most companies have a referral scheme in place to save money on recruitment costs. Networking with colleagues can be a great way to find out about potential career opportunities that may not be advertised or available through recruitment consultants.

Looking and Applying for Jobs

Upload your CV to online jobs sites, such as Total Jobs, Monster and Indeed. Be clear about the location and type of work you want or you may be inundated with irrelevant calls and emails from potential recruiters. On the other hand, don’t make the criteria too limited and be careful not to dismiss everything that doesn’t fit your criteria exactly. Some might still be good opportunities to pursue.

Your return to work gives you the opportunity to decide what kind of job you want and what your ideal terms would be. Be clear and honest with yourself about what you are looking for and what you can realistically commit to. By targeting the kind of job you want, you’re more likely to find something that meets your needs rather than hoping to negotiate suitable terms. If flexible working is an important criteria for you as it was for me, you can identify favorable companies by examining at their HR policies.

At first it seemed like I would have no chance of finding the part-time, home-based regulatory work that I wanted. Most advertised positions I saw were full time, very few were home-based, and none seemed to offer any kind of school holiday flexibility. But I stuck to my guns, told recruiters what I wanted and kept looking.

Be Proactive

I was sent a full-time position by a recruiter that I almost dismissed as I was only looking for part-time work. However, on closer inspection, I learned the company was very open to employees working from home, so I decided to pursue it. I found out who the head of regulatory was and sent my CV by email, along with more about me, my experience and what I could give in terms of hours and time. This outreach led to a telephone interview and eventually a job offer.

Flexible jobs are rarely advertised. They are usually negotiated by someone already with the company or you have to go out and seek them for yourself. Smaller companies may be more flexible than larger ones for opportunity to hire the right person.

Preparing for Interviews

As with any job interview, you need to do your homework on the company and its products. Most interviews for regulatory affairs jobs take the form of a competency style interview. For these, you will be asked to give examples of a time when you have demonstrated a certain skill set, behavior or attitude. You will need to be able to describe a situation or problem you have encountered, what actions you took to solve it and what the outcome was. The type of competencies you may be asked about can include communication, teamwork, analytical skills, leadership, independence and creativity.

To prepare for this type of interview, look at the type of competencies you think will be important for the role. The job description will usually include a list of skills and attitudes required. Use this list to come up with one or two examples from your prior work experience.

The two key things you’ll have to convince a potential employer of, after an extended absence from work, are your commitment to work and your technical ability.

Be ready to talk about your career break. Start thinking about your time away in a positive light. Did it give you needed time to raise your family and pursue other interests? Are you now coming back to the workforce with renewed vigor, excited to embrace new opportunities? Think of how you’ve added to your skill set with other activities you’ve been involved with such as volunteer work or taking courses. Make it clear your career break does not indicate a lack of commitment. Discuss your break but don’t apologize for it.

Regarding your technical and job skills, focus on your previous work experience, big projects you’ve worked on and the problems you were able to overcome in those. You will already have a list of all your skills, strengths and achievements. Review and be ready to discuss them.

Being able to start immediately without working a notice period also can be very attractive to an employer looking to fill a position quickly. This may give you an advantage over other potential candidates.

Don’t be shy in asking about flexible working policies, company culture and expectations. It is better that you know early on, rather than later when your child is sick or you need to attend a school event.

Volunteering as Opportunity to Prove Your Value

Volunteering to do a short-term project or assignment is a great way to let potential employers know what you are capable of. For the job I accepted, I opted to do a number of sample assignments as a gesture of good will. This was not compulsory for the job offer, but gave my future employer confidence in my ability to read and interpret the current guidance and apply basic regulatory skills.

Back in the Game

Once you start your new job you’ll likely find you have much to learn. There are new company systems and processes to become familiar with, finding your way around, learning who to contact for what and training to complete. It can be a bit overwhelming at first.

There is no substitute for on-the-job training in regulatory, and most of what you need to know you will pick up as you go along. Much of my getting back up to speed was done on the job. I read SOPs and sought out the latest guidance as I needed it for different projects. That’s the beauty of regulatory affairs, as long as you know where to find the guidance and the latest regulatory frameworks, and have the medical or scientific background to read and interpret them, you don’t need to know everything.

Whenever you start a new project or assignment, the first port of call is always the health authority websites for the latest guidance, templates and best practices. Also, look or ask for examples of recent work and, if possible, find a mentor to ask questions as they arise. Shared learnings are key to your success.

Managing Expectations and Working From Home

It’s important is to be realistic about what you can achieve during your working hours. You cannot do a full-time job in part-time hours. Part-time work requires excellent time management skills. You will still have the same training requirements as your colleagues, as well as objectives to prepare and meetings to attend.

You have to be flexible. Often meetings or training courses are held outside your working hours and you will still be expected to attend. You need to be acutely aware of the deadlines and co-dependencies in projects, highlighting your progress and meeting deadlines to ensure continued progress. The key to making all this work is good communication. Communicate with your manager and with project teams to manage expectations and ensure that both business needs and your family needs are being met.

I didn’t go back to managing large-scale global projects because it would not have been achievable. However, I have been involved with some really interesting smaller-scale projects which are more suited to my part-time hours, but still offer challenges and professional development opportunities. This has included everything from mature brands licence maintenance (CMC variations and CCDS labelling updates) to pre-submission projects (writing a briefing document for scientific advice, SmPC development, writing clinical responses to Day 180 Centralised procedure EMA questions and writing preclinical and clinical eCTD modules). I love the variety of work, and I can work with shorter deadlines and achieve the satisfaction of completing important projects on a daily basis.

Working from home can feel a little bit isolating because you don’t experience the same face-to-face interactions. Modern communications technology helps alleviate that to some degree, but you do need to be motivated, disciplined and dedicated to working from home to avoid getting distracted.

The rewards of returning to work, including renewed financial independence, job satisfaction, professional networking and being able to make use of my qualifications and experience, have been well worth the effort. I love being able to work and also be there for my family.


The regulatory environment is constantly changing and returning from a career break means you will have a lot to catch up on. However, it is relatively easy to get back up to speed on regulations and procedures. What doesn’t change are the skills required to do the job. These don’t disappear during a career break and you will likely have new skills and enthusiasm to offer a potential employer when you return.

A career break is not professional suicide. It’s a wonderful opportunity to slow down and see what’s really important in life and to return to work with renewed vigor, revitalized and excited about what you can contribute. It’s also a chance to negotiate a work-life balance, with hours and flexible working arrangements, that fulfil both the company’s needs and your personal needs.

About the Author

Olivia McBride is a senior regulatory affairs consultant at Parexel. She can be contacted at


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