Regulatory Affairs Specialist (Domestic – Indian Market)

Position:

Location:

Qualification:

Drugs & Cosmetics Act and Rules

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.