Regulatory Affairs 

Specialists assist in obtaining and maintaining government approval for

drugs, medical devices, nutritional products, and related materials

consulting is offering your opinion (the business of giving expert advice to other
professionals), outsourcing is hiring someone else for their
opinoin/services. Outsourcing would be hiring consultants rather than using in house
staff employees. It all depends on your use of the word "is". Commonly companies
will outsource support for pc's and some applications

Outsourcing is the business practice of hiring a party outside a company to perform

services and create goods that traditionally were performed in-house by the company's
own employees and staff. Outsourcing is a practice usually undertaken by companies
as a cost-cutting measure

- ProductLife Group is a leader in providing regulatory and pharmacovigilance

outsourcing consulting services to the global life sciences industry.

- ProductLife Group is headquartered in Paris, France and has global offices in

countries across Europe, the Middle East, Asia, Africa, Latin American and
North America.  Founded in 1993, the company boasts an enviable client
roster including 75% of the world’s top pharmaceutical companies who rely
on ProductLife Group’s support and regulatory affairs services across the
product life cycle – from development to postmarketing safety surveillance.

- 8 of top 10 pharmaceutical companies, 25 years continuous operations

- ProductLife Group offers pharmaceutical regulatory affairs outsourcing and consulting services
-  team of regulatory affairs service providers have extensive knowledge and wide-
ranging expertise that span all types of products: traditional pharmaceuticals,
generics, cosmetics, vaccines, biologics, biosimilars, and other advanced therapies.
- ProductLife Group has been working with this client for more than five years to see that
European Medicines Agency (EMA) submission requirements get met.
- a partner with global and local regulatory expertise handles all activities with regard to national
competent authorities’ requirements as well as all of the procedures and activities associated
with each product in each country or region—from planning to tracking.

ProductLife Group is an outsourcing and consulting services company that supports the
global life sciences industry across the product development and marketing life cycle by
transforming the way organisations capture, monitor, manage, and use information.
We specialise in helping major life sciences organisations improve time to market with
flexible, information-based services.

eDMS ( electronic data management system) – effective management of workflow  involves

creating a central hub where all important documents are stored along with a security system
that ensures only approved personnel are able to view classified documents ( capture, store,
indexing, workflow)
An issue tracking system (ITS) is a software application that allows an enterprise to record
and follow the progress of every problem or "issue" that a computer system user identifies until
the problem is resolved
An issue tracking system (ITS) is a software application that allows an enterprise to record
and follow the progress of every problem or "issue" that a computer system user identifies until
the problem is resolved

Make a plan – follow up

A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an

organization to help workers carry out routine operations. SOPs aim to achieve efficiency,
quality output and uniformity of performance, while reducing miscommunication and failure to
comply with industry regulations.

Fsop

Hello

I am currently working as a Clinical Pharmacy intern in Cluj-Napoca where I advise and

consult / assist (with) the physician or the pharmacy specialist in providing a good
pharmacotherapy for the pacient. The past two years I have helped my fellow colleagues in
maintaining a rational and safe therapy. I have reported to my superiors any potential
adverse events or drug interactions and I have informed them of any discrepancy I may
have encountered and, thus I have a great attention to detail. I have also followed- up the
problem to see if and how the issue was resolved. I have also learned that there is a lot to
learn every single day and after each day I tried to read and expand my knowledge.

In addition, I have had many university projects that helped me in developing my research
and communication skills as I had to present them in front of my professor and my
colleagues. Some projects required me to work with other people and I had managed to
devide equally the tasks and to work well within the team.

I have also recently finished my Master’s Degree in Pharmacovigilence where I had gained a
lot of knowledge about national competent authorities, clinical trials, adverse reactions,
research methodology, good pharmacovigilance practices and so on. My master’s thesis
paper was about some specific cardiovascular and gastrointestinal AR of the
antidepressants SSRI where made a synthesis of the suspected AR stocked in
Eudravigilance. This is when I became more and more interested in Pharmacovigilance and
Regulatory Affairs.

From my experience in community pharmacy I have learned how to cope with challenging
and difficult situations, how to work under stress and how to make the pacient understand
my explanation and to paciently answer all his or hers questions. I have also managed to
quickly learn the process behind the pharmacy software that managed patient and drug
info, work flow, inventory, reporting etc.

I am enthusiastic about the opportunity of learning new things in a domain I am most

interested of. I emphasise on the fact that I am eager to learn and to become a better
version of myself as I am a hard-working and resilient person.

Because After careful consideration, I have come to the decision that following this path
would be the most suitable for me because I want to expand my knowledge in regulatory
affairs and my master’s in Pharmacovigilance has made me realize that I want to better
myself and I believe your company would be the best for me.

See myself in 5 years: My hope is to learn as much as possible about banks and banking
services. My short-term goal is to become an excellent cashier and then, possibly move on to
jobs with more responsibility in the bank as I gain experience and knowledge about banking.
Longer-term, my goal is to become a supervisor, possibly in customer service, loan processing,
or another aspect of banking. My hope is that this is the beginning of a long career working for
this bank, which progresses logically.

So far, my greatest accomplishment was earning my Masters's degree in Pharmacovigilance

while working as a Clinical Pharmacy intern as I have acquired a great set of skills.

Greatest weakness – I tend to accept too many tasks that can make me feel a little burnt out, but
I am learning to improve this be setting a daily list of realistic tasks.
I believe entering the regulatory affairs domain is a great opportunity for me to learn new skills
and to expand my area of experience. I have learned many things at my current job, but I this
opportunity in this company fits very well with the direction I want to take my career. 
 “I noticed that the parts of my previous positions I enjoyed the most were those that aligned with what’s
listed in your job description
“After getting an offer, I am able to start two weeks later to provide time for my current role to be filled.

Skills: regulatory knowledge, critical thinking,

But to become an RA specialist, the theoretical knowledge on legislations
governing medical products and the understanding of the technicality
involved in regulatory submission would be an added advantage.
Teamwork: evaluate the individual strengths of my associates, communicate well
with them, and coordinate my efforts to support theirs. Working as a team
member has the advantage of coming up with the best ideas from each
invididual’s brainstorming. I believe people in a team should listen carefully to
one another,communicate effectively, but also manage any conflictual situations
in a  non-confrontational manner. I can honestly say that I’m comfortable both in
working independently as well as in contributing to teams.
- Collaborative working environment
- I believe working as a team encourages the members to have a more
proactive way of thinking and it helps them express theirs opinions and
ideas more easily. It also helps the new members understand more rapidly
the company’s policies and procedures in order to become more
experienced
- Exemple of team work: recently I had two person team project where we
discussed the key points we wanted to add into the project and then divied
equally those key points. As our research progressed I realized that we
had to change our project objectives in order to make a well rounded
project and my colleague agreed so we both showed what we had found in
our researched and explained why we thought a specific information would
suit the best. We collaborated well, were honest and I enjoyed the open
communication that we had and the willingness of an open mind
I worked on a textbook sales team during a slow summer season. I scheduled brainstorming meetings
where our group could come together to find innovative solutions and new sales tactics. We took the
time to listen to everyone’s ideas, and by the end of the summer, we had exceeded our sales goals by
20%.”

Here are a few example questions you might consider asking:

What kind of training would be? What would I be required to do on a typical day?

 What does a typical day look like for a person in this position?
 How has this role grown or adapted to suit the needs of the organization?
 What kind of growth does the company expect to see within the next five years?
 Do you have any concerns about my experience or skill set?
 Thank you for explaining the role to me in such depth. When might I hear back
from you regarding next steps in the process?
 What are the next steps in this process?
 Hi Jen,
 It was great speaking with you over the phone today. I really enjoyed
learning more about The Muse’s mission to help people find companies
and careers they love, and especially enjoyed discussing your vision for
expanding the consumer product. I’d absolutely love the opportunity to
join your team.
 I look forward to hearing from you about next steps, but please let me
know if there’s any other information I can provide in the meantime.
 All the best,
Alyse

d Working Practice Documents (WPDs) This purpose of this Working Practice Document (WPD) is to
describe the informed consent process for participants in the Ambition trial. This is to be used in
addition to the Clinical Informed Consent WPD, which describes how the medical and nursing teams
should approach the patient and their families, perform cognitive assessment and document consent

Whereas SOPs are top-level documents that tell employees which actions to take under a variety of
circumstances, work instructions describe those actions in detail

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals

for Human Use (ICH) is an initiative that brings together regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product
development and registration

https://www.linkedin.com/pulse/regulatory-affairs-interview-questions-answers-anupama-reddy/
What are the procedures for Approval of Drug in EU?

Ans.

Centralised Procedure (CP)

Decentralised Procedure (DCP)

Mutual Recognition Procedure (MRP)

National Procedure (NP)

CTD- common tehnical documone tThe CTD dossier is divided into five main modules: Module 1 –
Administrative information and prescribing information; Module 2 – Overviews and summaries of
Modules 3–5; Module 3 – Quality (pharmaceutical documentation); Module 4: Non-clinical reports
(pharmacology/toxicology); Module 5: Clinical study reports (clinical trials).nical document

ICH – M4

QRD- quality review of documents – template of SmPC pe care orice companie care doreste sa puna pe
piata un me de obligata sa il faca

Detailed information of the scientific development is available in the PAR( public assessment report)

SmPC- summary of products charecteristics

The official body regulating how these documents are written and translated is
the European Medicines Agency (EMA). Any pharmaceutical company that
wants to market their products in any EU member state must submit a
marketing authorisation application through a centralised procedure. As part
of this procedure, the company needs to prepare the product’s SPC, PIL and
label in compliance with the so-called Quality Review of Documents (QRD)
template which contains the approved headings and dictates what needs to be
included in these documents in every member state
 A Key Performance Indicator (KPI) is a measurable value that demonstrates how effectively a
company is achieving key business objectives. Organizations use KPIs to evaluate their
success at reaching targets.

Quality Assurance Integral to ensuring success in the outsourcing of affiliate regulatory activities are
both training and establishing key performance indicators (KPIs).
ProductLife Group performs all of the regulatory affairs activities required to obtain new local marketing
authorisations and to maintain existing ones

ProductLife Group provides support across the following activities: • Regulatory life-cycle management,
including: – Type 1/minor variations – Type 2/major variations – Renewals – Periodic safety update
reports – Line extensions – Deregistration/discontinuation • Handling of responses to questions from
health authorities • Packaging activities such as packaging change requests based on labelling changes,
artwork updates, and mock-up preparation • Translation activities • Approval management • Handling
of postapproval commitments • Providing regulatory intelligence with regard to new or revised
legislation ( https://productlifegroup.com/wp-content/uploads/2016/07/PLG_Brochure_Global-
Markets_FINAL_20160715.pdf )

KPIs are established to determine whether project objectives are being met. KPIs include: •
Communication via meetings, status reports, and progress reports • Evaluation of regulatory submission
timelines • Quality of information collection and application content • Packaging materials that reflect
current requirements for specific individual markets • Tools for archiving of relevant documents in the
client’s database

ProductLife Group is looking for a REGULATORY AFFAIRS ASSISTANT in Cluj-Napoca!

ProductLife Group is the European industry-leading specialist service provider for the Life
Sciences industry, focused on delivering high quality professional services in the areas of
Regulatory, Safety, Quality, Process alignment and Medical services. All ProductLife Group’s
services are targeting support for comprehensive compliance and safety throughout the
product life cycle, therefore enabling continuity and productivity of product development and
subsequent processes.

Regulatory Affairs Assistant

We are seeking for a Regulatory Affairs Assistant who will contribute to Regulatory activities
performed on the RA Platform/the Hub. Regulatory activities include pre-licensing activities,
new registration (sites and medicinal products), post licensing regulatory submissions,
interaction with health authorities on behalf of PLG customers.

We are looking for someone with proven understanding of the regulatory process of the
pharmaceutical industry, with excellent organisational and interpersonal skills, with ability to
work and interact smoothly within an international team. For this role we are seeking a
professional with excellent communication skills in English. Finish and/or other Nordic
languages are a plus.

Job Description:

 Contribute to the creation of client administrative documents to be included in

regulatory submissions ( docs that you give for approval);
  Compile ( put together) regulatory dossiers in accordance with national requirements;
 Systems management and administration;
 Document and track regulatory submissions and regulatory authority approval;
 Provide regulatory support to clients and associate companies;
 Liaise (cooperate) with sponsor head-office and affiliate departments on regulatory
issues;
 Liaise with external regulatory authorities as required;
 Provide review of packaging texts;
 Provide format review of Summary of Product Characteristics (SmPD, Patient
Information Leaflets and labelling (. QRD-qualiy review documents- compliance check);
 Provide on-going regulatory support to the Regulatory Affairs Manager and to project
teams;
 Contribute to data entry in PLG tools enabling measurements of KPI, metrics for
regulatory services supplied by the platform/hub;
 Assist in the preparation of SOPs (standard operating procedure) and WPDs (work
practice documents);
 Assist in the management of ProductLife Ltd’s Quality Management System;
 Participate in trainings developed for ProductLife employees;
 Support the Pharmacovigilance group in the production of Regulatory Authority and
Ethics Committee documentation;
 Liaise with external regulatory authorities as required, notably in case of technical
invalidation;
 Comply with the company’s policies and procedures to meet statutory, quality and
business requirements within the overall strategy and objectives.

Requirements:

 Bachelor’s degree in a science related field;

 1-year experience in a regulatory affairs or equivalent;
 Good understanding of regulatory tracking database software(helps the business meet
the regulatory requirements), eDMS, MS Word, MS Excel and good computer skills;
 Effective oral and written communication skills in English (written fluency a must, verbal
fluency preferred);
 Additional knowledge in Finish and/or other Nordic languages are a plus;
 Excellent organizational (ability to meet deadlines-proiecte, sesiune, decision making
cand farmacistul sef era plecat-leadership, collaboration,issue analyzing and
interpersonal skills (motivation, responsibility, listening);
 Process orientated with good attention to detail; (master, projects, verificarea fisei de
obs pentru pharmacotherapy problems
 Ability to work well within a team ( projects, community pharmacy team).
PSURs are pharmacovigilance documents intended to provide an evaluation of
the risk-benefit balance of a medicinal product at defined time points after its
authorisation. (takes into account new or emerging safety information)

Regulatory Information Management Software (RIMS) - A

productive RIMS organizes the work needed to obtain approval to sell human medical products
RIMS is a growing software category that streamlines the submission of human medical
products—including pharmaceuticals, biologics, and medical devices—to regulatory
agencies, ultimately to gain authorization to sell the said product in a given market. In
general terms, Regulatory Information Management Software (also known as
Regulatory Information Management Systems) are software systems that:

a. manage product dossiers including regulatory product information,

b. aid in the preparation of product submissions in regulated formats, and
c. manage the submission of information in approved formats to regulatory
agencies

RIM can be defined as the capability to support global regulatory activities.

 regulatory intelligence, is already one of the big growth areas in the life sciences industry.
Described by the EU Regulatory Intelligence Network Group as the act of processing
targeted information and data from multiple sources, analysing the data in its relevant
context and generating a meaningful output to the regulatory strategy, it is considered a
must by more and more companies.

Regulatory strategy could be seen as the adaptaFons a company makes to move its product from the
development state to achieving markeFng approval. • Regulatory strategy incorporates the drug
development plan, an outstanding issue or quesFon, background informaFon, regulaFons and/or
guidance documents, strategic advice and recommendaFons on implementaFon. • The definiFon all
depends on the company you work for, their culture and needs and the backgrounds of the people who
trained you

Regulatory InformaDon Databases

• Provide worldwide regulatory informaFon (over 75+ countries) for both drugs and devices •
Explanatory documents that guide you through a country’s drug/device registraFon process – How to
start a clinical trial – Maintenance of a clinical trial – Adverse Event ReporFng – ScienFfic Advice –
Orphan applicaFon – How to construct a markeFng applicaFon – How to deal with variaFons or changes
of marketed products

• Use to compile, manage and archive informaFon • Global regulatory informaFon available instantly •
InformaFon frequently reviewed can be bookmarked for easy reference • Documents can be printed for
hard copy archival • Provide daily or weekly updates (they provide surveillance and monitor the
landscape for changes

Regulatory management databases keeps you up to date with the ever changing regulatory
requirements, with the latest changes in regulations and guidelines

https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/west-
coast/regulatory-intelligence-101.pdf?sfvrsn=132b48e_4
eDMS - https://www.youtube.com/watch?v=bxHbP-q9InU&ab_channel=SERGroup

- hub where the high secure documents are stored, automated and manged in a way that
helps employyes comply with regulations
- digital replication of documents and records

https://prestigescientific.com/10-steps-in-the-art-of-preparing-for-a-regulatory-job-interview/
MAA- marketing authorization application
DCP- decentralized procedure
https://www.hma.eu/medicinesapprovalsystem.html
eSubmissions
https://www.proclinical.com/blogs/2015-4/how-to-prepare-for-your-regulatory-affairs-job-
interview
https://www.hma.eu/medicinesapprovalsystem.html
https://prestigescientific.com/10-steps-in-the-art-of-preparing-for-a-regulatory-job-interview/

Competency based questions

Describe a situation when: situation, action, result, ( star technique)

When preparing for a competency-based interview, we advise following these four

steps.

 Find out what competencies the employer’s looking for.

  Identify competency question examples.
 Develop a story for each competency.
 At interview, pick the right story for the right questio

For STAR-based questions you split your answer into four sections. STAR stands for:

 Situation: Describe the background or context.

 Task: Describe the task or challenge you were faced with.
 Action: Explain the action you took, and how and why you did it.
 Result: Describe how it ended, what you accomplished and what you learned
from the situation. Relate the skill or ability you’re illustrating back to the
vacancy you’re applying for and explain why it’s useful.

To score highly, you’ll need to show the following:

 You deal with problems positively.

 You can compromise.
 You have a willingness to learn.
 You’re aware of your own limitations.
 You need to show a willingness to accept help and grow from your
experiences.
 You can handle pressure.