Regulatory Professionals :Goals and Roles

· Regulatory Affair Associate:
This profile is more about providing consultancy,where a person can play a lead role as a decision making considering all pros and cons.This type of role will suit people who enjoys taking tasks as a challenge, want additional responsibility, and enjoy the buzz and pressure of a dynamic environment.


Regulatory Affairs Assistants:
Providing administrative Regulatory support for timely delivery of products by assisting with technical support.
Prepration and submission of design dossier with approval body
Preprations for FDA and notified body inspection.
Assembly and submission of design dossier and technical document.


Quality Assurance Associate:
Again Pharmaceutical Quality Assurance professionals work as consultants

To provide audit and quality assurance services to ensure product success.
They play a vital role in developing pharmaceutical products that protect patient safety and ensure regulatory compliance.
By employing their vast skills and resources, professionals with their experience and knowledge to save money, minimize your risk and facilitate your project speed.

Quality Assurance Investigators

§ Professionals possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP's/ Change controls/ Deviations) as per various regulatory agencies.

§ Professional supports other member of regulatory teams in review and filing of various dossiers in US/EUROPE/CANADA/MCC/BRAZIL and various regulatory agencies across the globe.

§ Professionals Implements higher standard of quality in all areas of ANDA submissions for Tablets / Capsules /Dry Syrups/Oral solutions.

§ Professional assists in preparation of supplements, annual reports and amendments,Review of Stability data/Trends/Impurity profiles and perform various regulatory inspection.

• 
  Documentation Administrators
  Plan and organize internal and external meetings and teleconferences.
  Liaise with CROs, clinical sites, Clinical Investigators and others, as required
  Maintain paper-based and electronic files for Clinical and Regulatory departments
  Ability to develop and maintain indexing and filing system for Clinical and Regulatory documentation in line with regulatory requirements
  Receive, identify and file documentation in accordance with filing system.
  Generate listings of documents received and filed.
  
  Medical Information Associate:
  
  Professionals will be involved in setting up new global processes and systems to align all affiliates & distributors for medical information.
  
  Professionals act as the key point of contact for medical information enquiries locally & from international affiliates.
  
  Professionals are Responsible for composing written & verbal responses to internal and external customers.
  
  They are also responsible Literature searches & literature reviews and updating medical information database.