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Regulatory Affairs Specialist

4 weeks ago

Mumbai, India Win in Life Academy Full time

Position:
Sr. Executive / Asst. Manager / Deputy Manager – Regulatory Affairs (Domestic)

Location:
Andheri, Mumbai

Qualification:
M. Pharm. (Experienced preferred)

Job Description – Regulatory Affairs (Domestic)

The role requires strong expertise in the
Drugs & Cosmetics Act and Rules
,
FSSAI regulations
, and
FDA-related activities
. The profile will ensure
timely and robust cross-functional coordination
(R&D, QC, Marketing, Legal, Production, etc.), transparent execution, and effective implementation of
regulatory affairs and safety processes
.

Local Regulatory Function (Licensing):

  • Prepare registration dossier for procuring certificates/licenses from
    Local FDA, DCGI, FSSAI, and through the Sugam CDSCO portal
    .
  • Thorough familiarity with
    FDA, Sugam CDSCO & FSSAI online portals
    , Drugs & Cosmetics Act, and its various Schedules (e.g., Sch Y, Sch M, etc.).
  • Confirm
    product formula and label acceptability
    , and ensure receipt of necessary licenses prior to product release.
  • Coordinate with
    QC and R&D
    for technical documents (batch records, specifications, analytical methods, validation reports, stability data) required for registration dossiers.
  • Ensure timely
    renewal of drug and food licenses
    maintained by head office and branch offices across India.
  • Apply online for obtaining
    test licenses for import purposes
    through
    Sugam CDSCO
    .
  • Maintain archival of all regulatory permissions.
  • Keep abreast of
    updates in regulatory requirements
    and ensure implementation.
  • Draft
    responses to legal & technical queries
    raised by Regulatory Authorities.

Compliance of Packaging Modules:

  • Formulate and implement
    statutory requirements
    pertaining to
    artworks
    (labels, cartons, package inserts, patient information leaflets, etc.).
  • Review and approve artwork for all packaging material.
  • Prepare
    package inserts
    as per
    New Drugs and Clinical Trials Rules 2019
    .

Pharmacovigilance:

  • Provide high-quality
    medical writing
    , including planning and coordination of literature research.
  • Draft and review
    PSURs
    with a focus on medical aspects and product safety sections.
  • Review
    Risk Management Plans (RMPs)
    as per Regulatory requirements.
  • Assess
    risk-benefit profiles
    of products and identify gaps in aggregate documents.
  • Perform
    scientific review
    of aggregate reports / ICSRs produced by PV Associates.