Drug Regulatory Affairs: Drug Regulatory Affairs refers to all aspects within

the pharmaceutical development process and how they are subject to various
degrees of regulation. The pharmaceutical law frame, guidelines covering Quality,
Safety and Efficacy as well as Health Authorities' attitudes and requirements etc.
have a major influence on the drug development process and the success of it.
Regulatory affairs professionals deal with these aspects. It actually refers to the
professionals who maintain regulations from within the industry. The
pharmaceutical industry is the most regulated of all industries. Regulatory affairs
professionals are key, but overlooked, players in drug development. They are the
primary communications link between the company and agencies such as FDA,
and they are responsible for keeping up with the increasing scope and complexity
of regulations. In the pharmaceutical industry, regulatory affairs professionals
have expertise in the legal and regulatory environments, as well as in clinical
research protocols.

Role of Regulatory Affairs in Pharmaceuticals : The regulatory

affairs (RA) department of a pharmaceutical company is responsible for obtaining
approval for new pharmaceutical products and ensuring that approval is
maintained for as long as the company wants to keep the product on the market.
It serves as the interface between the regulatory authority and the project team,
and is the channel of communication with the regulatory authority as the project
proceeds, aiming to ensure that the project plan correctly anticipates what the
regulatory authority will require before approving the product. It is the
responsibility of RA to keep abreast of current legislation, guidelines and other
regulatory intelligence. Such rules and guidelines often allow some flexibility, and
the regulatory authorities expect companies to take responsibility for deciding
how they should be interpreted. The RA department plays an important role in
giving advice to the project team on how best to interpret the rules. During the
development process sound working relations with authorities are essential, e.g.
to discuss such issues as divergence from guidelines, the clinical study
programme, and formulation development.
Most companies assess and prioritize new projects based on an intended Target
Product Profile (TPP). The RA professional plays a key role in advising on what will
be realistic prescribing information (‘label’) for the intended product. As a
member of the project team RA also contributes to designing of the development
programme. The RA department reviews all documentation from a regulatory
perspective, ensuring that it is clear, consistent and complete, and that its
conclusions are explicit. The department also drafts the core prescribing
information that is the basis for global approval, and will later provide the
platform for marketing. The documentation includes clinical trials applications, as
well as regulatory submissions for new products and for changes to approved
products. The latter is a major task and accounts for about half of the work of the
RA department.
An important proactive task of the RA is to provide input when legislative changes
are being discussed and proposed. In the ICH environment there is a greater
possibility to exert influence at an early stage.

The Responsibilities of the Regulatory Affairs Professionals:

The department of Regulatory Affairs is established to protect public health, by
monitoring and controlling the safety and efficacy of drugs within several domains
including pharmaceuticals, veterinary medicines, agrochemicals, cosmetics,
medical devices, pesticides, and complementary medicines. The primary role of
Regulatory Affairs is to provide strategic and technical advice to the
pharmaceutical companies, right from drug development to the successful
marketing of the product.They are also responsible for-
@ Stay connected with international legislation, guidelines and customer
practices
@ Keep up to the date with a company’s product range
@ Ensure that a company’s products comply with the current regulations.
@ The Regulatory Affairs professional’s job is to keep track of the ever-changing
legislation in all the regions in which the company wishes to distribute its
products. They also advise on the legal and scientific restraints and requirements,
and collect, collate, and evaluate the scientific data that their research and
development colleagues are generating.
@ Formulate regulatory strategy for all appropriate regulatory submissions for
domestic, international and/or contract projects.
@ Coordinate, prepare and review all appropriate documents for example
dossier and submit them to regulatory authorities within a specified time frame in
conjugation with the organization.
@ Prepare and review of SOPs related to RA. Review of BMR, MFR, change
control and other relevant documents.
@ Monitor the progress of all registration submission.
@ Maintain approved applications and the record of registration fees paid
against submission of DMF’s and other documents.
@ Respond to queries as they arise, and ensure that registration/ approvalare
granted without delay.
@ Impart training to R&D, Pilot plant, ADl and RA. Team members on current
regulatory requirements.
@ Advising their companies on the regulatory aspects and climate that would
affect proposed activities. i.e. describing the "regulatory climate" around issues
such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
@ Manage review audit reports and compliance, regulatory and customer
inspections.
@ Regulatory Affairs professionals help the company avoid problems caused by
badly kept records, inappropriate scientific thinking or poor presentation of data.
In most product areas where regulatory requirements are imposed, restrictions
are also placed upon the claims which can be made for the product on labelling or
in advertising.
@ Have a duty to provide physicians and other healthcare professionals with
accurate and complete information about the quality, safety and effectiveness of
the product.

Qualities of a good RA professional

Ø Authoritative
Ø Team Player
Ø Decisive
Ø resourceful
Ø Good Communication Skill
Ø Analytical Skill- Ability to evaluate the strengths and weakness of the technical
and legal options open to a company.
Ø Good Informational Technology skills
Ø Negotiating Skills
Ø Able to reapply scientific and regulatory principles
Ø Ability to work with other disciplines
Ø Flexible- Always willing to learn.

Functions of legal adviser Regulatory affairs professional: One of

the most common titles in the industry is regulatory affairs specialist. These
specialists analyze new and existing regulations in relation to an organization’s
products or processes. They also review marketing, legal, and technical
documentation, including case files and clinical research reports, to assess
compliance with global regulatory agency policies, regulations, and standards.
Regulatory affairs specialists may also recommend courses of remediation to help
companies achieve the necessary levels of compliance. Acting as a liaison
between manufacturing organizations and federal agencies, they may be
responsible for submitting critical regulatory documents, with the goal of
approval for sale and distribution.
Senior-level regulatory professionals often make strategic business decisions that
have significant legal and financial repercussions. A large part of a regulatory
affairs role, at all levels, is to interpret and communicate these implications to a
diverse set of internal and external stakeholders.
Regulatory professionals are also often a voice in conversations at the cutting
edge of health and public policy. Darin Detwiler, PhD, assistant dean, and director
of Northeastern’s Master of Science in the Regulatory Affairs of Food and Food
Industries program, says that regulatory work is more than a job; it’s a mission.
He says his goal as a regulatory leader and educator, “is not just to send students
forth with degrees, but to build effective leaders and change agents in the health
and food industries. Regulatory work is a big part of the solution to major public
health and food safety challenges.”
Medical & Regulatory Affairs : Whether your new product is a drug, a biologic, a
device or even a combination, we have the resources and proven expertise to
develop an appropriate development strategy created to fit your study’s goals.
We can provide comprehensive services from our facility or onsite in order to
meet your project needs. Our experts can help guide you throughout all phases of
clinical development, whether it is preparing the IND or IDE, providing medical
and regulatory services throughout each study, or preparing the NDA, MAA, or
PMA.
Included as part of our full global medical and regulatory affairs service offering,
we provide comprehensive Electronic Common Technical Document (eCTD)
services to support electronic submission to regulatory authorities. We offer all
aspects of electronic document preparation, document management, eCTD
publishing, submission management and Regulatory Authority submission.
SynteractHCR runs the entire program in-house for the Sponsor. SynteractHCR
team members understand the usage of the technology and benefits of the
platform – therefore, sponsors gain improved turnaround time and higher quality.
We provide easy access to members of the project team for clarification of any
data as needed. Perhaps most important for our sponsors, we are committed to
improving our Sponsors’ knowledge base as well, and we can walk them through
the process, explain requirements, and handle gap analysis as needed. Our team
of pharmacovigilance experts, including our expert physicians, will be there
throughout the clinical process to perform safety surveillance and reporting on
your studies. As a full-service clinical research organization, SynteractHCR also has
extensive post-marketing experience. Once your product is approved, we can
assist with post-marketing pharmacovigilance, periodic reporting, designing and
implementing phase 4 studies, preparing supplemental NDAs, drafting standard
responses and medical information letters, preparation of manuscripts and more.

Medical and Regulatory Affairs Services Include:

Regulatory strategy development and project management
Regulatory submissions (US FDA, Health Canada and EU)
Comprehensive eCTD Services to support electronic submission to regulatory
authorities
Representation with regulatory authorities
Preparation for and management of regulatory meetings
Preparation of IND, IDE, MAA, NDA, PMA, 510k
Medical monitoring
Safety surveillance
Regulatory reporting
Charter and interface with Data Safety Monitoring Boards and Advisory Panels
Standard operating procedures (SOP) review and development