responsibilities, role and scope of DRA Professionals

1. Regulatory Affairs
By:
Tanuja Bisht
Associate Professor

2. Content:
Responsibilities
Scope for RA professionals
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3. Responsibilities of RA Professionals
 In the current competitive environment, reducing the time needed to reach the market is
essential for the success of a product and, therefore, for the company.
 Good RA professional will have a “right first time” approach and will play a very important
role in coordinating scientific effort with regulatory needs throughout the life of product,
helping to maximize the profitable use of corporate resources.
Qualities for good RA professionals:
 Good analytical skills
 Good negotiating skills
 Judgement skills and presentation skills
 Good communication skills
 Good computer skills as they need to perform certain tasks like preparation of reports and
analysis of data.
 Project management skills are of utmost importance to perform different type of tasks.
 Ability to update on current regulations.
 Team player, decisive, flexible and always willing to learn.
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4. I. Role in Health Authorities (HA)
a) Evaluation of MAA:
RA professionals performs following functions:
 Evaluation of marketing authorization application such as application for new drugs,
medical device, biological products, cosmetics, generic, clinical trial.
 Prepare drug master files for API, excipients and packaging materials etc.
 Issue comments/assessment of evaluation to manufactures.
 Manages application, post approval changes and track annual updates and maintain the
records.
 Post marketing approval management.
 Issues certificate for marketing authorization approval, GMP and GCP approval.
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5. b) Input for guidelines and guidance documents:
 Issues guidelines and guidance documents to maintain quality, safety, efficacy and price
control of drugs as well as implementation of CTD.
 For exchange of technical knowledge, to know about GMP status and product approval
collaborates with global and regional harmonization units.
 Facilitates management of pharmaceutical business within countries smoothly thereby
minimizing barriers by decreasing duplicate generation of technical data.
c) Inspection:
 RA personnel perform GMP audit for site of drug manufacturing unit
 GCP audit for clinical study site and bio-equivalence center and issues certificate
confirming the approval status.
d) Support to Pharmaceutical Manufacturers:
 Supports manufacturer in defining pathway of drug development, during pre-NDA
meeting and provides comments and suggestions thereby confirming the drug
development pathway.
 Conducts timely meeting with pharmaceutical manufacturers association to discuss
technical issues, ongoing challenge, guidelines and future development of product.
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6. e) Monitoring of Drug Safety and Efficacy:
 Monitors drug safety by collecting Pharmacovigilance data and time to time reviewing
drugs in markets through labels and accordingly taking appropriate actions if required.
 Monitoring of results obtained from clinical trials and approval of study results for the
next phase of the study.
 Allows rapid designation of essential drugs for the patient population.
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7. II. Role of RA in Pharmaceutical Industry
a) Regulatory strategy for drug development:
Regulatory strategist play an important role in following areas:
 Plays crucial role during drug products selection for specific market.
 Being a part of business development activities, marketing and project team
meeting performs several functions.
 In consultation with specified health authority, defines the forms of application
i.e, new drug or generic application.
 Define clinical regulatory pathway, regularly meet health authorities.
 Prepares Global regulatory plan (GRP) defining chemistry, manufacturing and
control (CMC), clinical and non-clinical requirements etc.
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8.  Give advice to R&D tem to develop product at laboratory scale with
compliance of regulatory criteria.
 Provide help in execution of validation for manufacturing batches,
defining batch number, batch size, criteria and justification for
specification, evaluation of technical data.
 During bioequivalence or bioavailability study, defines study protocol and
helps in getting concurrence from respective health authority.
 Also involved in deciding labelling requirement for generic submission and
while making replica of innovator labelling information.
 Play key role in applying for site inspection to comply with GMP.
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9. b) Marketing Authorization Application:
 Perform crucial role in deciding type of submission type such as NDA, New Biologic
Application (NBA) and Clinical Trial Application (CTA) etc.
 Coordinates in preparation of type of drug master files for active substance and
excipients, site master file and packaging material master file.
 Prepares formal application for MAA to respective health authority.
 Justify application of the file with recommendation and precedence of regulatory
agencies, as well as with global and regional requirements.
 Provide technical evaluation and support during authority inspection to
manufacturing and clinical sites.
 Drafts queries and responses in time with prior discussion to HR.
 Supports in drug submission or approval calendar preparation and predict timeline
in approval for drug product.
 Submit pharmacovigilance study data to health authority for marketed products.
 Applies for withdrawal or cancellation of drug application, if required.
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10. c) Health Authority Relationship:
 Play crucial advisory role in defining guidelines from industry point of view.
 Gives applicable suggestions and comments to draft guidelines and circular.
 Develop health working relationship with evaluators of health authority.
 Keep updates about current regulatory guidelines an several upcoming changes.
d) Regulatory Systems and Processes:
 Maintains and keep records of drug product submission and approval through database
for regular and timely submission in future.
 For efficient management of drug regulatory guidelines and their compliance, prepares
SOPs.
 Provide internal training to staff to keep them update about regulatory environment.
 Always try to be part of regulatory forums, conferences, webinars and seminars
conducted to exchange regulatory knowledge.
 Stores all submitted documents in an organized manner through information technology.
 Arrange software for on-line submission of Common Technical Dossier (CTD).
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11. Scope for RA Professionals:
 Pharmaceutical Products:
 In pharmaceutical industry, he role of RA professionals is to provide all legal
information’s, such as updates on changes to the law, inventions of new drugs and
drug development projects, patents, trademarks and copyrights.
 Latest good manufacturing practices, scientific and technological updates and
related regulatory aspects, post marketing surveillance of the product for the
compilation of the pharmaceutical industry documentation.
 Internationally, many countries require common technical document (CTD) to
register medicines or authorize the marketing of products.
 CTD is the set of documents that guarantee the quality, safety and efficacy of the
pharmaceutical or organic products that must be prepared in accordance with the
requirements of the regulations prescribed by the authority of the Indian govt.
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12.  Medical Devices:
 Plays an important role in the product lifecycle, for example: can advice the team on
regulatory strategies to ensure that the product is legally marketed.
 Once the product design is complete, the RA product development team of experts will
provide a successful marketing presentation. And finally, these companies will rely on
them for post-marketing surveillance to confirm this to FDA if they are not functioning
properly.
 Biotechnology companies:
 Organic products need to be redirected through scientific progress and new quality
control procedures need to be stopped without sufficient discussion.
 There is an increasing demand for pre clinical tests of biotechnological products.
 With the development of biotechnology industries, it has catalyzed numerous changes
in drug regulation around the world, with a major blow to the regulation of non-natural
product.
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13.  Clinical Research:
 RA professional plays important role in the field of clinical research to make safe and
effective products.
 Have role in R&D phase of product and they are supposed to keep themselves updated
in terms of procedures, regulatory policies, and trends.
 Anyone having sufficient qualification and knowledge can enter as clinical research
coordinator or drug safety associate at their entry-level.
 Personnel with experience can enter as clinical research associate or investigator.
 Nutritional products & Cosmetics Industries:
 In these industries also, strict regulatory guidelines are followed during manufacturing,
packaging and marketing.
 So to confirm their regular and proper implementation, RA professionals are recruited
in nutritional and cosmetic industries.
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