3 Months Online/Classroom Program | Job-Oriented Program | Alternate Classes | Professionally Curated
Our Advanced Drug Safety & Regulatory Affairs Training Program is designed to equip you with in-demand skills in Drug Safety, Pharmacovigilance, Regulatory Compliance, and Risk Management.
Gain expertise in drug safety reporting, adverse event monitoring, regulatory guidelines (ICH-GCP, FDA, EMA), signal detection, risk assessment, and scientific documentation. This program prepares you for careers in pharmaceutical companies, CROs, regulatory agencies, and healthcare organizations.
✅ Online/Classroom Training | ✅ Career-Focused | ✅ Industry-Aligned
☑️ Open to Science Graduates, Freshers & Professionals Seeking Career Transition
☑️ B.Pharm, M.Pharm, and Pharm.D
☑️ B.Sc, M.Sc, and Ph.D. (Biotechnology, Microbiology, Biochemistry, Nursing, etc.)
☑️ B.E., B.Tech, and M.Tech (Biotechnology, Biomedical Engineering)
☑️ BPT, MPT, BDS, BAMS, BHMS, and MBBS
Introduction to Drug Regulatory Affairs
Overview of Regulatory Affairs:
Definition, scope, and significance in the pharmaceutical industry.
Regulatory Authorities and Frameworks:
Roles of global and national regulatory bodies (e.g., US FDA, EMA, CDSCO).
Understanding key regulations and guidelines governing pharmaceuticals.
Drug Development Process:
Stages from discovery to market approval.
Differentiation between innovator and generic drugs.
Regulatory Documentation and Submission Processes
Investigational New Drug (IND) Applications:
Purpose, structure, and submission requirements.
New Drug Application (NDA) and Abbreviated New Drug Application (ANDA):
Compilation, review, and submission procedures.
Common Technical Document (CTD) Format:
Structure and organization of Modules 1-5.
Electronic Submissions:
Utilization of eCTD and other electronic submission gateways
Good Regulatory Practices
Good Manufacturing Practices (GMP):
Principles focusing on US cGMP regulations and WHO guidelines.
Good Laboratory Practices (GLP):
Standards for non-clinical laboratory studies.
Good Clinical Practices (GCP):
Ethical and scientific quality standards for clinical trials.
Good Documentation Practices (GDP):
Accurate and consistent documentation methodologies.
Regulatory Compliance for Pharmaceuticals and Medical Devices
Regulatory Requirements for Pharmaceuticals:
Compliance activities throughout the drug product lifecycle.
Medical Device Regulations:
Classification, development steps, and lifecycle management.
Quality Assurance and Control:
Implementing and maintaining quality systems in compliance with regulatory standards.
Emerging Trends and Career Development in Regulatory Affairs
Pharmacovigilance and Post-Marketing Surveillance:
Monitoring and reporting adverse drug reactions.
Regulatory Considerations for Biologics and Biosimilars:
Approval pathways and regulatory challenges.
Career Pathways in Regulatory Affairs:
Roles and responsibilities at various levels.
Strategies for professional growth and continuous learning.
This modular approach ensures that participants acquire a solid foundation in drug regulatory affairs, preparing them for roles such as Regulatory Affairs Associate, Regulatory Affairs Specialist, and Compliance Officer within the pharmaceutical industry.
Growing demand for skilled professionals driven by the increasing global emphasis on drug safety, regulatory compliance, and risk management.
Advancements in AI, big data analytics, and automation are transforming drug safety monitoring, regulatory submissions, and signal detection processes.
Expanding career prospects in pharmacovigilance, medical writing, regulatory affairs, drug safety surveillance, and compliance management.
High-Demand Job Profiles in Advance Drug Regulatory Affairs
Regulatory Affairs: Associate, Specialist, Manager
Regulatory Compliance: Officer, Submission Specialist, Documentation Specialist
Drug Registration & Labeling: Registration Officer, Labeling Compliance Specialist
Regulatory Strategy & Operations: CMC Specialist, Regulatory Strategy Manager, Global Regulatory Associate
Consulting & Intelligence: Regulatory Consultant, Intelligence Analyst
Salaries range from ₹3 LPA to ₹25 LPA, based on experience and expertise.
Entry-Level: ₹3–5 LPA
Mid-Level: ₹7–12 LPA
Senior Roles: ₹20 LPA+
✔ Skills & Experience: Expertise in regulatory submissions, compliance (FDA, EMA, CDSCO), and tools like eCTD, IDMP boosts pay.
✔ Employer Type: Pharma companies offer higher salaries than CROs and consultancies.
✔ Location: Bangalore, Mumbai, Hyderabad, and Pune have higher pay scales.
✔ Education & Certifications: Advanced degrees (M.Pharm, M.Sc., Ph.D.) and certifications (ICH-GCP, RAC) enhance earnings.
Regulatory Associate → Regulatory Specialist → Regulatory Manager → Director of Regulatory Affairs
Transition Opportunities:
Regulatory Affairs → Pharmacovigilance / Medical Affairs / Quality Assurance / Clinical Compliance
Growing Demand:
Increasing global regulations → Expanding pharmaceutical markets → High demand for skilled professionals
Actual Fee: ₹60,000
One-Time Payment: ₹55,000 (with discount)
Installment Option: Available
Discounts, offers, and scholarships can be discussed with our admission counselor. Enroll now to avail applicable benefits.
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You will get access to the Career Ambitious Academy portal, where you can explore all training materials, live and recorded classes, and expert guidance. This ensures you have everything you need for a successful journey with Career Ambitious.
At Career Ambitious, we provide a prestigious certification upon successful completion of our program. Our certification is aligned with industry standards and is ISO-certified, ensuring its credibility and recognition across various sectors.
At Career Ambitious, we empower students with the skills and resources needed to excel in their careers. While our structured placement process focuses on resume enhancement, interview preparation, industry networking, and career guidance. Through expert mentorship and strategic career support, we help students build confidence, refine their skills, and navigate diverse job opportunities. Our goal is to equip students with the skills and knowledge needed for continuous professional growth in competitive industries.
