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Regulatory Affairs Pharmacist

Regulatory Affairs Pharmacist

MSN LaboratoriesKuala Lumpur, Kuala Lumpur, Malaysia
1 hari lalu
Penerangan pekerjaan
  • Responsible for the review and submission of registration dossiers to NPRA for all pharmaceutical products.
  • Familiarity with Malaysian regulatory frameworks with local guidelines and standards, up to date with changes. Updating new requirement changes.
  • Delegating work to the regulatory affairs team for smooth operations with respect to submissions
  • Maintain Life cycle management of the drug product.
  • Coordinate and monitor import permits, samples etc.
  • Liaising with regulatory body to ensure market access and compliance.
  • Responsible for the application of good manufacturing practices (GMP) and follow up for site inspections and issuance of cGMP certificates.
  • Coordinating & submitting new registration, renewal and variation dossiers
  • Fast-tracking & Ensuring the timely obtaining of registrations
  • Assist In-House Regulatory team in addressing the queries raised by Regulatory Agencies.
  • Submission of tender documents, samples and the final tenders to relevant organization wherever applicable.

    • Market Access

    • Develop and implement Market Access plan of actions to increase patient access.
    • Engage with healthcare authorities, payers, policy makers to develop long term partnership to build a positive platform for MSN and its brands.
    • Collaborate closely with medical affairs and commercial teams to align market access strategies with overall brand strategy
    • Support the development of pricing strategy for reimbursement in the public and private sectors
    • Work on contracting / managing the entry agreement price, capping, discounting etc.
    • Work closely with medical team in analysing clinical data prospectively and retrospectively post-launch to generate real world evidence.

      • Desired Qualifications

    • Must be a Registered Pharmacist in Malaysia
    • Strong commend in English (Read, write & speak)
    • Min. 5-6 years of Successful track record in regulatory filings / market access
    • Prior experience with access-related strategies e.g., pricing, reimbursement, advocacy, public policy.
    • Enjoy working in cross-functional, often virtual and with global teams

      • Seniority Level

      Mid-Senior level

      Employment Type

      Full-time

      Job Function

      Other

      Industries

      Pharmaceutical Manufacturing

      Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

      #J-18808-Ljbffr

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