Lowongan Kerja Jakarta Raya Posisi Associate Regulatory Affairs Manager di PT Bayer Indonesia

Gambar PT Bayer Indonesia Posisi Associate Regulatory Affairs Manager
  • Loker diposting 2 tahun yang lalu

Telah dibuka lowongan pekerjaan dengan sistem untuk posisi Associate Regulatory Affairs Manager di perusahaan PT Bayer Indonesia untuk kota/kab Jakarta Raya dan sekitarnya.

Pengalaman yang kita inginkan ialah Layanan Kesehatan & Farmasi serta orang yang mampu mengemban pekerjaan dengan baik.

Perusahaan ini tidak memiliki syarat yang spesifik terhadap calon pelamar sehingga anda dapat mencoba melamar ke perusahaan ini dengan memberikan CV atau portofolio anda.

Gaji yang perusahaan ini tawarkan cukup kompetitif menurut dari kemampuan pekerja. Rata-rata upah yang kami tawarkan adalah UMR/UMP daerah masing-masing. Namun itu semua bisa berubah menurut dari keputusan HRD.

Info Loker

Perusahaan PT Bayer Indonesia
Posisi Associate Regulatory Affairs Manager
Tempat Jakarta Raya
Tingkatan Kerja Tidak Terspesifikasi
Kualifikasi Tidak terspesifikasi
Jenis Pekerjaan
Spesialisasi Dibutuhkan Farmasi, Layanan Kesehatan
Gaji Min Rp. 1.800.000
Gaji Max Rp. 5.500.000

                 YOUR TASKS AND RESPONSIBILITIES

1.Determine local regulatory strategies and manage operational tasks to fulfill the local business strategies for the assigned CH portfolio, in coordination with the local functions and with close coordination with Team Lead RA CH and othe regional/global regulatory units. Ensure transparent, timely and efficient communication with business, supply chain and other local-regional-global functions, providing regulatory expertise to achieve common goals. Effectively manages priorities of assigned portfolio and/or geography.

2.Delivers regulatory affairs milestones for assigned CH portfolio and/or geography

a.Compile local submission files based on the documentation provided by global regulatory partners and present them to the respective authorities in accordance with local regulations and local requirements ensuring timely submission/approval with optimal labelling

b.Supports local licensing activities from RA aspects

c.Conduct regulatory assessment and provide recommendation to local business on regulatory feasibility, including regulatory risk assessment and mitigation proposal

3.Ensure regulatory compliance:

a.Supports and implements change management activities in cooperation with other functions and global RA

b.Initiates and tracks local implementation of labelling changes based on the CCDS and in accordance with SOP

c.Provides relevant information on RA milestones and documents submitted to global RA for incorporation into global database, MAAs (Marketing Authorization Application) and variations

d.Ensure global and local registration database are updated

e.Maintenance, update and renewal of product licenses in compliance with global standard and local regulations

4.Supports labeling management review process of promotional materials for assigned Bayer portfolio. Provide up-to-date labeling according to the latest approval as reference to be used by marketing and medical in the development and finalization for approval.

5.Liaise with the manufacturing site to support the key project from RA aspect and complete all RA-related tasks as per SOP, including facilitating the meeting with HA, if needed.

6.Represent Bayer as a competent, reliable partner to the local Health Authorities in all regulatory matters, to enable timely approvals with optimal labels. Proactively shape the regulatory environment in the country by participation – as needed – in industry association groups to create an effective network as well as proactively influencing the direction of regulatory policy in alignment with Bayer Indonesia.

7.Report to Team Lead RA CH.

WHO YOU ARE

  •          Pharmacist / Apothecary Degree, with at least 5 years of relevant experience in regulatory affairs with proven track record and experience in health authority interactions and negotiations and regulatory submissions and approval across various therapeutic areas and categories e.g. Rx, OTC, Medical Device, Health Supplements, Cosmetics. Successfully managed with minimal managerial oversight major filing (eg. NDA, new indication, site transfers) complex issue management.
  •          In-depth understanding of CMC, labeling, advertisements, clinical & nonclinical, BE report aspects for regulatory submission & approvability; Pharmaceutical industries licensing requirement
  •          Fluent in English and ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills.
  •          Detailed understanding of the operating procedures and policies of the national health authority. Overview knowledge of regulations in other AP countries, US, EU, etc.
  •          Ability to focus on multiple issues at one time, ability to organize, prioritize and work under time pressure.
  •          Ability to develop effective solutions to diverse and complex business problems, providing high degree of accuracy and reliability
  •          Meticulous
  •          Able to work independently but at the same time is a good team player
  •          Good time management skills 
  •          Computer literacy
  •          Good document organization skills

Alamat Lengkap

Provinsi DKI Jakarta
Kota Jakarta Raya
Alamat Mid Plaza I, Lantai 11, Jl. Jenderal Sudirman No.15, RT.10/RW.11, Karet Tengsin, Kecamatan Tanah Abang, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10220
Map Google Map

Keuntungan Kerja

  • Mendapat pengalaman kerja
  • Bonus jika lembur
  • Diajari terlebih dahulu

Lamar kerja

Perlu diingat informasi yang tertera bisa saja berubah sewaktu-waktu.

Melamar pekerjaan tidak dipungut biaya, anda harus berhati-hati saat melamar pekerjaan.

Pastikan anda mengisi form lamaran yang dituju terlebih dahulu dan menunggu HRD perusahaan menghubungi untuk interview.

Disclaimer: pastikan anda membaca deskripsi dan intruksi dari lokercepat.id agar tidak mengalami kejadian yang tidak mengenakkan saat melamar pekerjaan. Karena kami adalah situs berbagi lowongan pekerjaan dengan sumber dari internet, koran, dan TV.

Tips dari admin. Gunakan bahasa yang sopan dan promosikan diri semenarik mungkin agar HRD/Staff terkait tertarik dengan anda.

Semoga sukses mendapat pekerjaan yang diinginkan.

Intruksi Melamar Pekerjaan

  1. Buka link "Lamar Sekarang" di atas
  2. Jika belum punya akunnya, silahkan daftar terlebih dahulu, buat profile/unggah resume sesuai dengan data diri anda
  3. Jika sudah mendaftar kalian bisa langsung login
  4. Promosikan diri anda lewat form lamaran kerja yang tertara
  5. Selesai, silahkan tunggu.

Bagikan Loker ini

Deskripsi Perusahaan

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power.

Our products are helping to address some of today’s biggest challenges, including global population

growth, an aging society and the need to make efficient – and, wherever possible, sustainable – use of natural resources.

We are improving people’s quality of life by preventing, alleviating or curing diseases. We are helping to provide an adequate supply of high-quality food, feed and renewable plant-based raw materials.

In line with our mission “Bayer: Science For A Better Life”, we aim to improve people’s quality of life.

For this endeavor, we focus on our core competency of developing and successfully commercializing innovative products and solutions based on scientific knowledge.

Info Perusahaan

  • Industri: BioTeknologi/Farmasi/Riset klinik
  • Ukuran Perusahaan: 1001 - 2000 pekerja
  • Tunjangan dan Lain-lain: Asuransi Gigi, Tip, Asuransi kesehatan, Pinjaman, Olahraga (contoh: pusat kebugaran), Waktu regular, Senin - Jumat, Bisnis (contoh: Kemeja)
Loker ini cocok untuk anda yang tinggal di provinsi: DKI Jakarta