Deskripsi Pekerjaan

  • Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. 
  • MSc, MBA or PhD may be an advantage 
  • Experience in regulatory affairs, preferably in human medicines - minimum 5 years of experience.
  • Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
  • Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.
  • Regional Regulatory experience including knowledge of ANDA, MAA submission processes and Product lifecycle management processes.
  • Demonstrate experience of effective delivery in a matrix environment.
  • Knowledge of Regional Regulatory environment
  • Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks. 
  • Knowledge of drug development, regulations and guidelines
  • Leadership and management qualities, including good communication, negotiation, and  interpersonal skills
  • Understanding of pharmaceutical industry, clinical trials and pharmacovigilance
  • Knowledge and understanding of quality systems, processes, audit and inspection
  • Ability to influence peers in the organization
  • Team player
  • Analytical thinking
  • Change agile
  • Manage new to market submissions for assigned products
  • Develops submission and approval strategy (including timelines) and execution in alignment and partnering with key stakeholders (i.e. PGS, Markets, Clusters, Labeling team, Submissions Management, CMC) to ensure a submission ready dossier.
  • Liaise with Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations.
  • Ensure a submission planning and forecasting tool is utilized to update timelines when necessary, communicate changes to relevant partners.
  • Capable of authoring local submission documents in relevant databases
  • Ensure submission packages are reviewed against local requirements for consistency and completeness
  • Liaise with the manufacturing sites for obtaining supporting documents as needed
  • Ensure thorough understanding and application of the Hub procedures
  • Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
  • Assist in ensuring internal regulatory processes and procedures are well documented.
  • Assist Regional RA leads drive improved efficiencies across the region through achieving consistency in post approval strategies and its execution.
  • Understand local regulations and trends, as communicated by the PCO.
  • Maintain an active partnership with the Regional Lifecycle Hub so they ensure post approval commitments are met.

Tentang Perusahaan

Deskripsi Perusahaan
PT Pfizer Indonesia merupakan anak perusahaan dari Pfizer Incorporated yakni perusahaan internasional asal AS yang bergerak di bidang kesehatan. Perusahaan yang didirikan pada tahun 1849 ini mempekerjakan sekitar 106.000 karyawan pada tahun 2005 dan terus berkembang hingga saat ini. Pfizer menghadirkan produk-produk dan obat-obatan yang mendukung kesehatan tubuh dan pencegahan terhadap penyakit, juga penyembuhan untuk penyakit-penyakit lainnya. Dalam rangka memastikan untuk memberikan yang terbaik kepada pasien, pelanggan dan pemegang saham, Pfizer terus fokus pada pengembangan bisnis dan mengoperasikannya dengan penuh transparansi dan selalu mendengarkan masukan dari berbagai ahli kesehatan yang terlibat dalam pengambilan keputusan.

Jl MH Thamrin 1Menteng, MentengJakarta Pusat 10310 DKI Jakarta

No. Telepon

(021) 7451192

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