DRA Partner

Date Posted: 30+ hari yang lalu
Salary:
Roche
Jakarta
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Job Description

Ensure that product registration process is conducted in timely manner, comply to Health Authority’s requirements, and in accordance to the company’s SOP, to expedite the patient access to our products which are safe, effective and in standard quality.

Strategy Planning / Regulatory Policy

  • As assigned, participate in industry associations on regulatory policy and regulations; taking regulatory convergence into consideration
  • With guidance, contribute to global regulatory strategies, considering local regulation and business needs
  • As assigned, gather and disseminate regulatory intelligence within the Affiliate; involving regional and global organizations, when appropriate
  • Provide Regulatory Affairs input into relevant cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
  • Develop innovative, risk-based regulatory strategies and work plans for assigned products or business areas within the Affiliate to accelerate access in alignment with global

Strategy Planning / Regulatory Policy

  • As assigned, participate in industry associations on regulatory policy and regulations; taking regulatory convergence into consideration
  • With guidance, contribute to global regulatory strategies, considering local regulation and business needs
  • As assigned, gather and disseminate regulatory intelligence within the Affiliate; involving regional and global organizations, when appropriate
  • Provide Regulatory Affairs input into relevant cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
  • Develop innovative, risk-based regulatory strategies and work plans for assigned products or business areas within the Affiliate to accelerate access in alignment with global

Fillings

  • Adopt global product dossiers to local requirement
  • Prepare and manage regulatory registration fillings across product lifecycles
  • Interact and negotiate with local HAs and internal stakeholders to build and cultivate trusted partnerships
  • Ensure regulatory filings are aligned with commercial and supply needs to assure business continuity
  • Influence internal and external stakeholders for successful regulatory outcomes
  • Ensure good filing system both softcopies and hardcopies including keeping the document in secured place (clean desk policy) are well implemented

Regulatory Compliance

  • Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards
  • Ensure regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits
  • Ensure assigned Affiliate regulatory activities comply with Roche global standards and local regulations

Other

  • Supervise and manage relevant Affiliate regulatory activities on applicable Roche systems to ensure appropriate, thorough and timely regulatory information and document management
  • As assigned, supervise and manage end-to-end local product packaging and labeling from a regulatory perspective
  • Where applicable, supervise and manage or otherwise review and approve external communications materials to provide regulatory input and guidance to other Affiliate functions and teams
  • As applicable, supervise and manage shipment clearance/QA release of Affiliate materials/products
  • Support local market access activities from a regulatory perspective

Qualifications & Experiences

  • A pharmacist graduated from a reputable and accredited university.
  • Minimal 5 years of professional experience in pharmaceutical industry .
  • Have a solid understanding of BPOM regulations and have extensive experience in regulatory field.
  • Able to interpret regulatory requirements and guidelines.
  • Able to collaborate effectively and efficiently with commercial team, medical team, supply chain team, and CMO.
  • Able to effectively represent Roche to outside parties including BPOM personnel, CMO , and general public.
  • Agile method adoption
  • Excellent communication skills.
  • Ability to prioritize and organize varied workload while ensuring high level of attention to detail, accuracy, and compliance.

Knowledge

  • cGMPs , GDPs, GCPs, BPOM & ICH regulations
  • Registration requirements & procedures
  • Product profile
  • Industry knowledge of medicinal products.

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Job Detail

  • Job Id
    3060c86a0275272f
  • Location
    Jakarta
  • Company
    Roche
  • Type
    Private
  • Employment Status
    Permanent
  • Positions
    Available
  • Career Level
    Experience
  • Gender
    Male/Female

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