Drug Regulatory Affairs Professional

2 weeks ago


United Kingdom Igmpiindia Full time

Conferment of the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023" to IGMPI

Certified Drug Regulatory Affairs Professional

IGMPI has brought an opportunity to become a Certified Drug Regulatory Affairs Professional for those who understand the basic stages of the industrial production life cycle and their regulatory requirements. The certification would impart among the candidates the ability to examine specific regulations that governs the Pharma industry in USA, Europe, UK, Canada, Japan, India etc. The curriculum of the certification is designed as a comparative analysis of Pharma regulatory systems of different nations integrated with concrete management tools of the supply chain like, Certification schemes, Regulatory compliance with government guidelines, product approval procedures etc. To obtain the certification, candidate must clear the qualifying exam for which proper training materials will be provided by the institute. No extra charges will be applied for this material.

Our training for the preparation of this certification is aimed at improving the conceptual knowledge of the participant towards formation of efficient public policies, compliance with regulatory guidelines, the regulatory strategies of companies in the food industry, and resolving any dilemmas that a working professional may face at respective workplace. Successful performance in this exam implies that the participant has in-depth knowledge and clear understanding of industry guidelines and regulations. The study resources have been carefully designed to introduce the participant to various aspects and basics of industrial applications, its need, and benefits in assuring quality production.

The case study based approach in the training provided for the certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified Drug Regulatory Affairs Professional in the domain. An advanced training having rigorous case studies based methodology will be imparted to all participants to prepare for the Certifying Examination. The training in Regulatory Affairs imparted by IGMPI is approved and certified by Quality Council of India, Government of India.

Certified Study Resources

Module 1: Regulatory Authorities around the world
Module 2: Various stages in Drug development
Module 3: Introduction to the GMP concept
Module 4: Methodological regulatory filing around the world
Module 5: Common Technical Document Filing. eCTD submission process
Module 6: Intellectual Property Rights in Pharma Industry
Module 7: Quality Assurance and Drug Regulations, ICH and WHO guidelines
Module 8: Guidelines for Import and Export of Pharma products
Module 9: Audits by the Government and Regulatory bodies
Module 10: Breach reports and Compliance guidelines
Module 11: Drug Registration in African Countries.
Module 12: Drug Registration in Gulf (GCC) Countries.
Module 13: AYUSH Regulatory Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy)
Module 14: Industry specific case studies

Any Graduate/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

A comprehensive study material for all the modules in hard copies ensuring the needs of theaudience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • – Assignments for all the programme modules for continuous evaluation and guidance.
  • – Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
  • – Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
  • – All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
  • – Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
  • – At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
  • – All learning and training delivery initiatives shall be conducted in English.
Assessment & Certification

All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be certified as Drug Regulatory Affairs Professional by IGMPI. For all the above mentioned elaborate study resources, Assessment test papers and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well. The certification will be awarded after the required levels of knowledge, skills, professionalism and attitude are assessed through the IGMPI assessment process.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals workingwith global pharmaceutical, healthcare like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Bliss GVS Pharma, SeQuent, Mankind, Beryl Drugs, Allergy Therapeutics, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc.The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Moderated by Shri Vinod Arora, Principal Advisor, IGMPI (Building FR&D Talent in India)

Moderated by Shri Vinod Arora, Principal Advisor, IGMPI

Moderated by Shri Vinod Arora, Principal Advisor, IGMPI

Moderated by Shri Vinod Arora, Principal Advisor, IGMPI

Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like

#J-18808-Ljbffr

  • United Kingdom invoX Pharma Limited Full time

    Senior Regulatory Affairs Associate - Drug/Device (Contractor) Department: Regulatory Employment Type: Contract / Temp Location: invoX Remote (UK) Reporting To: Marie Morris Description Description of Services To help continue our growth and success, we are looking a Contract Senior Regulatory Affairs Associate to support the delivery of...


  • United Kingdom Igmpiindia Full time

    Conferment of the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023" to IGMPI Certified Drug Regulatory Affairs Professional IGMPI has brought an opportunity to become a Certified Drug Regulatory Affairs Professional for those who understand the basic stages of the industrial production life cycle and their regulatory requirements. The...


  • United Kingdom Immunocore Full time

    Regulatory Submissions, Manager Vacancy Name Regulatory Submissions, Manager Employment Type Permanent IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune...

  • Regulatory Specialist

    Found in: Appcast UK C C2 - 13 hours ago


    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...

  • Regulatory Specialist

    Found in: Appcast UK C2 - 15 hours ago


    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...

  • Regulatory Specialist

    Found in: Appcast Linkedin GBL C2 - 6 hours ago


    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...

  • Regulatory Specialist

    Found in: Whatjobs ES C2 - 6 hours ago


    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring,...


  • United Kingdom Hyper Recruitment Solutions Full time

    Are you looking for a new opportunity where your expertise will be pivotal in navigating the complexities of UK/EU regulatory frameworks? Based in Berkshire, this role offers the chance to become an integral part of a leading Pharmaceutical company, ensuring that innovative health solutions reach the market efficiently and safely. As a Regulatory Affairs...

  • Regulatory Affairs Executive

    Found in: Jooble UK C2 - 2 weeks ago


    United Kingdom Hyper Recruitment Solutions Full time

    Are you looking for a new opportunity where your expertise will be pivotal in navigating the complexities of UK/EU regulatory frameworks? Based in Berkshire, this role offers the chance to become an integral part of a leading Pharmaceutical company, ensuring that innovative health solutions reach the market efficiently and safely. As a Regulatory Affairs...


  • United Kingdom Meet Recruitment Limited Full time

    Senior Director, Regulatory Affairs (Generalist) Remote Position for West Coast-based candidates, frequent travel to Bay Area required Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs and will...


  • United Kingdom Janeiro USA, Inc. Full time

    This role will support the Global Regulatory Affairs department to propel the hypergrowth and rapid global expansion of the brand. Someone who loves the complexity and detail orientation of global regulatory, thrives in a fast-paced environment, and excels in a passionate, collaborative culture would be successful in this role. The position reports to the ...


  • United Kingdom PharmaGroww Full time

    Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile &...

  • Senior Manager/Director of Regulatory Affairs

    Found in: Jooble UK C2 - 2 weeks ago


    United Kingdom PE Global Full time

    PE Global is currently recruiting for a Regulatory Affairs CMC Manager for a contract role with a leading multinational Biotech client based in London – Fully remote within the UK. Regulatory CMC support for post-approval submissions for commercial products, predominantly biotechnology products and new international MAA filings predominantly in EMEA...


  • United Kingdom Meet Full time

    Job Title: Senior Regulatory Affairs Associate Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. Position Overview: As a...

  • Senior Regulatory Affairs Associate

    Found in: Appcast Linkedin GBL C2 - 1 week ago


    United Kingdom Meet Full time

    Job Title: Senior Regulatory Affairs AssociateLocation: Fully remoteCompany Description:We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team.Position Overview:As a Senior...

  • Senior Regulatory Affairs Associate

    Found in: Whatjobs ES C2 - 1 week ago


    United Kingdom Meet Full time

    Job Title: Senior Regulatory Affairs Associate Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. Position Overview: As a...

  • Senior Regulatory Affairs Associate

    Found in: Appcast UK C C2 - 1 week ago


    United Kingdom Meet Full time

    Job Title: Senior Regulatory Affairs AssociateLocation: Fully remoteCompany Description:We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team.Position Overview:As a Senior...

  • Senior Regulatory Affairs Associate

    Found in: Jooble UK C2 - 7 days ago


    United Kingdom Meet Full time

    Job Title: Senior Regulatory Affairs Associate Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. Position Overview: As a...

  • Senior Regulatory Affairs Associate

    Found in: Appcast UK C2 - 1 week ago


    United Kingdom Meet Full time

    Job Title: Senior Regulatory Affairs AssociateLocation: Fully remoteCompany Description:We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team.Position Overview:As a Senior...


  • United Kingdom Corin Group Full time

    Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK Req #233 04 April 2024 Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards,...