Job Opportunities For Regulatory Affairs Department At Medi Pharma Konnect

Regulatory Affairs in the Pharmaceutical Industry

Regulatory Affairs (RA) is a crucial department in the pharmaceutical industry responsible for ensuring compliance with global regulatory requirements set by agencies like the FDA (USA), EMA (Europe), MHRA (UK), TGA (Australia), WHO, and CDSCO (India). The RA department plays a vital role in obtaining approvals for drug manufacturing, marketing, and distribution while ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).

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Key Responsibilities of Regulatory Affairs:

1. Drug Development & Approval Process

• Guides drug discovery and development to align with regulatory requirements.
• Assists in clinical trial applications (CTA/IND) and marketing authorization applications (MAA/NDA/BLA).
• Works closely with R&D, Quality Assurance (QA), and Production to ensure compliance.

2. Regulatory Submissions & Documentation

• Prepares and submits regulatory dossiers, including:
  • Investigational New Drug (IND) application.
  • New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) for generic drugs.
  • Biologics License Application (BLA) for biologic products.
  • Common Technical Document (CTD/eCTD) for global submissions.

3. Compliance with Global Regulatory Agencies

• Ensures pharmaceutical products meet country-specific regulations.
• Maintains compliance with agencies like:
  • FDA (Food and Drug Administration, USA)
  • EMA (European Medicines Agency, EU)
  • MHRA (Medicines and Healthcare products Regulatory Agency, UK)
  • TGA (Therapeutic Goods Administration, Australia)
  • CDSCO (Central Drugs Standard Control Organization, India)
  • WHO (World Health Organization)

4. Labeling & Packaging Compliance

• Ensures drug labels, patient leaflets, and packaging meet legal and safety requirements.
• Reviews barcodes, batch numbers, expiry dates, and storage conditions.
• Aligns with FDA’s Drug Facts Label (DFL) and other international guidelines.

5. Post-Marketing Surveillance & Pharmacovigilance

• Monitors drug safety after market approval (Phase IV Clinical Trials).
• Reports adverse drug reactions (ADRs) and unexpected side effects to regulatory agencies.
• Ensures timely renewals, variations, and safety updates.

6. Regulatory Intelligence & Strategy

• Tracks evolving regulatory changes and guidelines worldwide.
• Provides strategic advice to management on regulatory risks and compliance.
• Assists in patent protection, exclusivity periods, and generic drug approvals.

7. Audits, Inspections, and Compliance Support

• Prepares for regulatory inspections (FDA, EMA, WHO, etc.).
• Ensures compliance with GMP, GCP, and GLP standards.
• Coordinates with Quality Assurance (QA) to meet audit expectations.

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Importance of Regulatory Affairs in Pharmaceuticals

• Ensures legal and ethical approval of drugs before market release.
• Prevents non-compliance penalties, recalls, and market withdrawals.
• Protects public health by ensuring medicines are safe, effective, and high quality.
• Facilitates global market expansion by obtaining international approvals.

Would you like details on Good Manufacturing Practices (GMP) or regulatory submission processes

Job opportunities with Regulatory Affairs department (Pharmaceutical)

Location Ahmedabad

1. Manager - Regulatory Affairs

Work Exp - 5 to 7 years / CTC - Up to 8.00 LPA

2. Sr Executive / Officer - Regulatory affairs

Work Exp - 3 to 5 years / CTC - Up to 5.00 LPA

3. Executive - Regulatory affairs

Work Exp - 1 to 3 years / CTC - Up to 3.00 LPA

Qualification - B.Pharma / M.Pharma / MBA

Mail id - medipharma.resume@gmail.com / 7201083211