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By: Irfan Sohail M. Phil (Pharmacognosy) LLB, DIPL, MA (Economics)

Irfan sohail

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By:

Irfan SohailM. Phil (Pharmacognosy)

LLB, DIPL, MA (Economics)

Regulatory Affairs

The regulatory profession is vital in making safe and

effective healthcare products.

Regulatory Affairs Professional

Assist to meet requirements established by regulatoryagencies in introducing new product to market.

Employed in:

• Healthcare Companies

• Regulatory Agencies

• Contract Research Organizations

• Independent Consultants

Scope of Regulatory Affairs

Strategic Planning

Pre-marketing

Post-marketing

Interfacing

Strategic Planning

Evaluate the regulatory environment and provide internaladvice throughout the product lifecycle

Perform risk/benefit analysis on product developmentconcept for initial product viability

Evaluate feasibility of safety and efficacy testing tocomply with regulatory standards

Strategic Planning

Provide regulatory intelligence to develop local,regional and global regulatory strategies

Identify appropriate regulatory authorities forsubmission of data and approval

Anticipate regulatory obstacles and provide alternativestrategies

Develop and review SOPs for regulatory compliance

Pre-marketing

Advise stakeholders with regulatory requirements forquality, preclinical and clinical data

Prepare registration dossier and submit to appropriateregulatory authorities

Interact with regulatory authorities during review process

Monitor progress of regulatory review throughappropriate communication

Pre-marketing

Timely respond to regulatory authorities queries andobservations

Participate in developing a risk management system (e.g.,vigilance) to ensure regulatory compliance

Identify, monitor and submit applicable reports (e.g.,Serious Adverse Events) or notifications (e.g., changes inmanufacturing or test method)

Post-marketing

Ensure regulatory compliance of labeling

Ensure regulatory compliance of advertising andpromotional items

Submit notifiable changes to update product informationand/or instructions for use

Ensure SOPs compliance to handle complaints, recallsand vigilance reports

Post-marketing

Ensure regulatory aspects of product manufacturing,testing and distribution

Maintain licenses (e.g., manufacturing, registration,controlled substances, sale)

Ensure compliance of import/export requirements

Ensure adequacy of product traceability systems

Miscellaneous

Interfacing

Communicate and negotiate with regulatory authoritiesand stakeholders to facilitate regulatory compliance

Co-ordinate company presentations to regulatoryauthorities to facilitate regulatory compliance

Provide input on proposed legislation, regulations,guidelines and standards

Accompany inspection and audit teams as required

Interfacing

Maintain records of legislation, regulations, guidelinesand standards to support strategic planning

Review public communications, press releases etc. toensure regulatory compliance

Communicate with legal counsel when regulatory bodyexceeds its authority

RA Profession & Product Lifecycle

Regulatory Core Competencies

• Scientific or Technical background

• Experience is a key asset for Regulatory Professionals

• Soft skills e.g., Communication, Problem solving &Decision making, Project management, Leadership etc.

• Continuing Education and Professional Development

• Up to date with Regulatory Policies and Procedures

Regulatory Core Values

Regulatory Compliance

Competency

Objectivity

Integrity

Honesty

Courage

Fairness

Respect

Development of RA Professional

Level I (Officer/Executive)

• Have basic knowledge and understanding ofregulatory requirements, legislation and processes.

• Coordinate and support in technical and scientificregulatory activities.

• Develop soft skills such as writing, project coordinationand interpersonal communication.

Development of RA Professional

Level II (Asst. Manager/Manager)

• Have integrated understanding of regulatory affairs as itapplies throughout the product lifecycle.

• Strong emphasis on technical aspects of the professionand project management.

• Expand its involvement in international regulatory issuesand regulatory strategies.

Development of RA Professional

Level II (Asst. Manager/Manager)

• Develop knowledge and skills in areas such as:

• regulatory pathways and options;

• risk-benefit analysis;

• communication and collaboration internally andexternally;

• submission, obtaining approval, documentation,compliance, vigilance;

Development of RA Professional

Level III (General Manager/Associate Director)

• Have strong technical and management skills and activelyengaged in regulatory strategy, business activities andorganizational management.

• Develop knowledge and skills in areas such as:

• Strategy development, Risk assessment andmanagement;

• Monitor change in the regulatory environment,Influence the regulatory environment;

• Staff development and management;

Development of RA Professional

Level IV (Director/Chief Regulatory Officer)

• Proactively develop innovative approaches for pursuingbusiness objectives within the regulatory framework.

• Strategic planning and interfacing throughout theproduct lifecycle.

• Engaged in policy development .

• Typically are leaders and mentors within theirorganization and for RA Profession.