Regulatory Affairs Overview in the Digital Age This captivating slide deck provides a comprehensive overview of the various departments within regulatory affairs, illuminates salary prospects, explores emerging trends, and unveils the exciting future that awaits professionals in this dynamic field. Prepare to be captivated by visually engaging slides that offer invaluable insights and equip you to harness the power of the digital revolution in regulatory affairs. Get ready to unlock a world of opportunities for success in the ever-evolving landscape of regulatory affairs.

1. Regulatory
Affairs
Overview
in
Digital Age
Sharan Murugan
01-May-2023

2. Introduction to Regulatory Affairs
Major Domains
• Pharmaceuticals – API, Excipients, Chemical & Drug Products
• Biotechnology
• Medical Devices
• Food & Cosmetics
• Veterinary
• Herbals
Regulatory Affairs
“The Bridge between Manufacturer & Health Agency”
Health Agency
• USFDA – USA
• EMA – Europe
• MHRA – UK
• HC – Canada
• TGA – Australia
Scope of RA & “The Future”
According to a report by IQVIA, the global pharma market reached $1.27 trillion in 2020 and is expected to grow at a
compound annual growth rate of 3-6% between 2021 and 2025.
According to a report by Grand View Research, the global regulatory affairs outsourcing market size was valued at
$6.3 billion in 2020 and is expected to grow at a compound annual growth rate of 12.1% from 2021 to 2028.

3. Different Teams & Salary in Regulatory Affairs
The Subdivisions (Different Teams in)* of Regulatory Affairs
• Regulatory Business Development
• Regulatory Strategy
• Regulatory Intelligence
• Regulatory Affairs (CMC)
• Regulatory Licensing
• Regulatory Labeling
• Regulatory Publishing
• Regulatory Life Cycle Management
• Regulatory Compliance (Audits)
• Clinical Regulatory
Regulatory Affairs Salary in UK (2022-23)
(1 UK = ~102 INR) ~ 1Cr. Rupees For 10 Year Experience in UK
In India
~12 Lakhs to 20 Lakhs INR for 10 Year Experience
(depending on the Company, Your Skills, & Value you add, etc.)
*Varies company wise and depends on many factors such as
MNC, Company size, Product portfolio etc.. Can be Team of
people or just a single or more experts..
Mostly in companies it is CMC & the Publishing team

4. Regulatory Business Development
Regulatory business development is a function that involves identifying
and pursuing new opportunities for growth and innovation in the
regulatory affairs field.
01.
02.
03.
04.
Conducting market research and analysis to identify
potential clients, partners, or projects that require
regulatory expertise or solutions.
Building and maintaining relationships with key
stakeholders, such as regulators, industry associations,
clients, and prospects.
Preparing and delivering proposals, presentations, and
pitches that showcase the value proposition and
competitive advantage of the regulatory services or
products offered.
Negotiating and closing contracts and agreements with
clients and partners.
Considerations for global regulatory strategies.

5. Regulatory Strategy
Regulatory Strategy department is responsible for providing strategic and technical guidance on
regulatory requirements, such as product development, approval, and lifecycle management.
Conducting regulatory
intelligence and research to
identify and monitor
relevant regulations,
guidelines, and best
practices.
Developing and
implementing regulatory
strategies for new and
existing products,
considering the regulatory
requirements, business
objectives, and market
opportunities.
Communicating and negotiating with
regulatory agencies to facilitate
product approvals and resolve issues &
Collaborating with cross-functional
teams
Evaluating the impact of regulatory
changes on products and processes and
proposing appropriate actions.
Providing regulatory advice/training to
internal and external stakeholders

6. Regulatory Intelligence
Regulatory Strategy department is responsible for providing strategic and technical guidance on regulatory requirements, such as product development,
approval, and lifecycle management.
Monitoring and research
various sources of
regulatory information,
such as legislation,
guidelines, policies,
standards, best practices,
and industry news.
Evaluating and
interpreting the impact
and implications of
regulatory changes or
developments
Supporting the development and
implementation of regulatory strategies
and plans for new and existing products.
Providing timely and accurate
regulatory updates, Establish, &
maintain regulatory intelligence
database. eg: Cortellis, Tarius,

7. The “Core” Regulatory
Regulatory affairs CMC refers to the (Authoring) development,
manufacture, and quality of pharmaceutical products, which involve the
chemical composition, formulation, manufacturing process,
specifications, stability, and analytical methods.
Conducting regulatory intelligence and research to
identify and monitor relevant regulations,
guidelines, and best practices.
Preparing and reviewing CMC sections of
regulatory documents, such as IND
applications, NDA, DMF, and variations.
Communicating and negotiating with
regulatory agencies to facilitate CMC
submissions and approvals and resolve
CMC issues.
Monitoring and evaluating the impact
of CMC regulatory changes or
developments on the products and
processes and proposing appropriate
actions.

8. The “Core” Regulatory
A regulatory submission is a formal application made to a regulatory authority seeking
approval to market a product or service.
The submission process can vary depending on the product, regulatory authority, and
country. Eg: IND, NDA (USA), CTA, MAA (EU)
Labeling team involves ensuring the
compliance and consistency of the
labeling information of a
pharmaceutical product.
Developing and implementing labeling
strategies and plans.
Preparing and submitting labeling &
artwork information to regulatory
agencies for approval, such as CCDS,
PIL, SPC etc.
Regulatory publishing involves
preparing and submitting regulatory
documents in electronic format to
regulatory agencies, such as the FDA &
EMA.
Formatting, bookmarking, hyperlinking,
validating, and compiling regulatory
documents, using eCTD Publishing Tools.
Submit the Dossier to HA, using
electronic submission gateways (ESG)

9. Emerging Trends and Future of Regulatory Affairs
eCTD (4.0)
Real-World
Evidence
(RWE)
IDMP
IoT & IoB
Big Data
& Block Chain
AI & ML
SKILLS THAT CAN'T BE KILLED
1. Communication and Writing skills
2. Critical Thinking and Problem-solving skills
3. Intermediate Computer Skills
4. Dedication to Fine detail
5. V-Shape Learning

10. Thank you
Sharan Murugan