Medley Pharmaceuticals Limited is a multidivisional and multi-location organization with a strong presence in Pharmaceutical formulations. The specialties include Hematinics, Anti ulcerants, Antibacterials, Pain management, Gynecology & cardiovascular drugs. We specialize in Iron preparations, our mega-brand being R.B.Tone Syrup. We also have much 1st time in India brands to our credit like Dompan (Domperidone & Pantoprazole), O2 (Ornidazole & Ofloxacin), Tazocef (Tazobactum & ceftriaxone) & Ostium k2 (1st brand of Vitamin K27 combination in India)

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Medley employs more than 3000 people, of which approximately 2200 are part of the sales force, around 700 associates in corporate & manufacturing across India & 100 in International Business.

Medley ranks amongst the top 40 pharmaceutical companies in India as per ORG IMS.

Position: Assistant Manager – Regulatory Affairs

Location: Daman, Daman & Diu

Job Description:

  • Coordination and review of administrative data required for dossier submission.
  • Coordination with Production, Store, QC, and R&D for archival of regulatory samples, packing component, Working standard & analytical data
  • Monitoring of New Material Introduction and New Product Introduction activities for ANDA & EU Dossiers.
  • To prepare requirements for FDA applications related to FSC, COPP, additional product licenses, tender documents, etc.
  • To maintain license documents and other FDA documents.
  • Review and Co-ordination for the Gap Analysis for the Regulatory News Letters and follow-ups for the closures of identified actions.
  • Coordination, tracking, and follow up with production and IPQA concerned for Sample requirement for various countries.
  • Providing registration details along with registration certificates to plant concerns in coordination with RA-HO.

  • Review and issuance of Registration compile status and respective addendum to all plant concerns within a stipulated period.
  • Reviewing and approval of product conversion form for the different countries based on the need of the International business in coordination with Regulatory Affairs –HO.
  • Reviewing and approval of BMR, BPR on behalf of Regulatory affairs.
  • Preparation of various MHRA correspondence letters for QP and third party Contact person for variation and Market complaint explanation
  • Preparation and Review of Annual Product Quality Review.
  • Preparation and Review of SOP.
  • To ensure continuous system improvement by reviewing documents and carrying out self-inspection of various departments in the plant.
  • Evaluation, review, and closure of change control, deviation, FIRCAR, CAPA, Market complaint, NMI, NPI, Periodic Extension, and Quality Risk Management.
  • To assist in the investigation of market-compliant, deviation, and other non-conformances reported.
  • Timely escalation of open QMS documents.

Qualification: B.Pharma/B.Sc, MS/M.Sc/M.Pharma

Experience: 5-10 Years

Salary: Negotiable

Contact Details:

hr@medleylab.com

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