Regulatory Associate Manager

2 weeks ago

Bengaluru, Karnataka, India GSK Full time
Nama Site: Bengaluru Luxor North Tower
Tanggal Posting: Apr

Job Purpose :

  • Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.
  • Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing Organizations and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers.
  • Will serve as a mentor/trainer for new team members.

May act as a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department.

Key Responsibilities :

  • Independently and confidently executes agreed dossier strategy.
  • Independently manages multiple Rx and/or Vx project assignments simultaneously; assignments will range in complexity, but more complex work is expected.
  • Independently completes data assessment to ensure dossier is fit for purpose.
  • Identifies risks associated with submission data and information packages.
  • Escalates issues with line manager that have business impact.
  • May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems.
  • Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff.
  • Understands internal/external Regulatory environment.
  • Actively builds an organisational network (PSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.
  • Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.

Job-Related Experience

  • Minimum 6-10 years of experience
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
  • Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  • Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
  • Ability to build effective working relationships and work in a matrix environment effectively
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.

Tujuan kami adalah menjadi salah satu perusahaan perawatan kesehatan yang paling inovatif, berkinerja terbaik, dan tepercaya di dunia. Kami meyakini bahwa kami semua membawa sesuatu yang unik ke GSK, dan dengan memadukan pengetahuan, pengalaman, dan gaya kami, dampaknya akan luar biasa. Bergabunglah dengan petualangan kami di GSK, di mana Anda akan terinspirasi untuk melakukan yang terbaik bagi pasien dan konsumen kita. Tempat di mana Anda menjadi diri sendiri, merasa baik, dan terus berkembang.

Pemberitahuan penting kepada Bisnis/Agen ketenagakerjaan

GSK tidak menerima rujukan dari bisnis ketenagakerjaan dan/atau agen ketenagakerjaan dalam kaitannya dengan lowongan yang diposting di situs ini. Semua bisnis/agen ketenagakerjaan harus menghubungi departemen pengadaan komersial dan umum/sumber daya manusia GSK untuk memperoleh otorisasi tertulis sebelum merujuk kandidat ke GSK. Mendapatkan otorisasi tertulis sebelumnya merupakan prasyarat sebelum perjanjian apa pun (lisan atau tertulis) antara bisnis/agen ketenagakerjaan dan GSK. Jika otorisasi tertulis tersebut tidak diperoleh, maka tindakan apa pun yang dilakukan oleh bisnis/agen ketenagakerjaan akan dianggap telah dilakukan tanpa persetujuan atau perjanjian kontrak dengan GSK. Dengan demikian GSK tidak bertanggung jawab atas biaya apa pun yang ditimbulkan oleh tindakan tersebut atau biaya apa pun yang ditimbulkan oleh rujukan apa pun oleh bisnis/agen ketenagakerjaan dalam kaitannya dengan lowongan yang diposting di situs ini.

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