Lowongan Associate Regulatory Affairs Manager di PT Bayer Indonesia
Nama Perusahaan
PT Bayer IndonesiaLokasi
Jakarta RayaKisaran Gaji
Tidak disebutkanTgl Dibuka
19 Februari 2023 - 11 Maret 2023Deskripsi Pekerjaan
         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
- Â Â Â Â Â 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.
- Â Â Â Â Â In-depth understanding of CMC, labeling, advertisements, clinical & nonclinical, BE report aspects for regulatory submission & approvability; Pharmaceutical industries licensing requirement
- Â Â Â Â Â Fluent in English and ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills.
- Â Â Â Â Â Detailed understanding of the operating procedures and policies of the national health authority. Overview knowledge of regulations in other AP countries, US, EU, etc.
- Â Â Â Â Â Ability to focus on multiple issues at one time, ability to organize, prioritize and work under time pressure.
- Â Â Â Â Â Ability to develop effective solutions to diverse and complex business problems, providing high degree of accuracy and reliability
- Â Â Â Â Â Meticulous
- Â Â Â Â Â Able to work independently but at the same time is a good team player
- Â Â Â Â Â Good time management skillsÂ
- Â Â Â Â Â Computer literacy
- Â Â Â Â Â Good document organization skills
Tingkat Pekerjaan
Pengalaman Kerja
Spesialisasi Pekerjaan
Kualifikasi
Jenis Pekerjaan
Ukuran Perusahaan
Industri
Tunjangan dan Lain-lain
Lowongan pekerjaan di PT Bayer Indonesia lainnya
Nama Pekerjaan | Kisaran Gaji | Tgl Dibuka |
---|---|---|
Packaging Technologist Executive | Tidak disebutkan | 16 Januari 2023 - 13 Februari 2023 |
QC Chemical Analyst | Tidak disebutkan | 15 Januari 2023 - 19 Januari 2023 |
Supply Chain Excellence Manager | Tidak disebutkan | 15 Januari 2023 - 10 Februari 2023 |
Project & Engineering Manager | Tidak disebutkan | 16 Januari 2023 - 08 Februari 2023 |
Manager CP Quality - SEA | Tidak disebutkan | 16 Januari 2023 - 08 Februari 2023 |
Equipment Technician | Tidak disebutkan | 21 Januari 2023 - 18 Februari 2023 |
e-Key Account Manager | Tidak disebutkan | 28 Januari 2023 - 24 Februari 2023 |
A/F Operator | Tidak disebutkan | 06 Februari 2023 - 05 Maret 2023 |
Digital Marketing Manager | Tidak disebutkan | 18 Februari 2023 - 10 Maret 2023 |
Corn Traits Lead, APAC | Tidak disebutkan | 19 Februari 2023 - 18 Maret 2023 |
QC Senior Chemical Analyst | Tidak disebutkan | 05 Maret 2023 - 23 Maret 2023 |
QA Oversight Supervisor | Tidak disebutkan | 03 Maret 2023 - 23 Maret 2023 |
QC Chemical Analyst | Tidak disebutkan | 10 Maret 2023 - 24 Maret 2023 |
Medical Representative - Solo | Tidak disebutkan | 03 Maret 2023 - 29 Maret 2023 |
Value Stream Manager | Tidak disebutkan | 11 Maret 2023 - 02 April 2023 |
Line Leader | Tidak disebutkan | 11 Maret 2023 - 02 April 2023 |
Central PM Technician | Tidak disebutkan | 04 Maret 2023 - 02 April 2023 |
Central PM Supervisor | Tidak disebutkan | 05 Maret 2023 - 02 April 2023 |
Shift Line Owner | Tidak disebutkan | 11 Maret 2023 - 02 April 2023 |
Line Maintenance Planner | Tidak disebutkan | 11 Maret 2023 - 02 April 2023 |
Manufacturing Leader | Tidak disebutkan | 11 Maret 2023 - 02 April 2023 |
Medical Science Liaison | Tidak disebutkan | 04 Maret 2023 - 02 April 2023 |
Supply Planning Executive | Tidak disebutkan | 11 Maret 2023 - 02 April 2023 |
Line Technician | Tidak disebutkan | 04 Maret 2023 - 02 April 2023 |
Manufacturing Manager | Tidak disebutkan | 11 Maret 2023 - 02 April 2023 |
Reliability & Maintenance Technician​ | Tidak disebutkan | 28 April 2023 - 08 Mei 2023 |
Reliability & Maintenance Supervisor | Tidak disebutkan | 28 April 2023 - 08 Mei 2023 |
Reliability & Maintenance Supervisor | Tidak disebutkan | 28 April 2023 - 08 Mei 2023 |
Area Leader | Tidak disebutkan | 28 April 2023 - 08 Mei 2023 |
Internship Program | Tidak disebutkan | 13 Mei 2023 - 29 Mei 2023 |
SHF Partnership Manager | Tidak disebutkan | 28 Mei 2023 - 01 Juni 2023 |
Internship Program | Tidak disebutkan | 26 Mei 2023 - 29 Mei 2023 |
Indonesia & Malaysia Channel Development & Value Optimization Lead | Tidak disebutkan | 28 Mei 2023 - 01 Juni 2023 |
Quality Testing Manager | Tidak disebutkan | 28 Mei 2023 - 01 Juni 2023 |
Product Manager | Tidak disebutkan | 26 Mei 2023 - 11 Juni 2023 |
Medical Representative - Palangkaraya | Tidak disebutkan | 28 Mei 2023 - 12 Juni 2023 |
CS Country Commercial Lead ID & MYS | Tidak disebutkan | 16 Mei 2023 - 14 Juni 2023 |
Territory Manager Area Lampung | Tidak disebutkan | 28 Mei 2023 - 15 Juni 2023 |
Manufacturing Planning Executive | Tidak disebutkan | 20 Mei 2023 - 17 Juni 2023 |
Materials Planning Executive | Tidak disebutkan | 19 Mei 2023 - 17 Juni 2023 |
Supply & Capacity, Product Launch & PDM Associate Manager | Tidak disebutkan | 22 Mei 2023 - 17 Juni 2023 |
Material and Manufacturing Planning Manager | Tidak disebutkan | 26 Mei 2023 - 17 Juni 2023 |
Industry Affairs Manager CS APAC | Tidak disebutkan | 28 Mei 2023 - 23 Juni 2023 |
Strategy Deployment and Capabilities Manager | Tidak disebutkan | 04 Agustus 2023 - 03 September 2023 |
Training Officer (Internship) | Tidak disebutkan | 07 Agustus 2023 - 06 September 2023 |
Product Specialist - Jakarta | Tidak disebutkan | 07 Agustus 2023 - 06 September 2023 |
Utility Technician | Tidak disebutkan | 08 Agustus 2023 - 07 September 2023 |
IT Manufacturing Associate Manager | Tidak disebutkan | 08 Agustus 2023 - 07 September 2023 |
Maintenance & Repair Inventory Analyst | Tidak disebutkan | 09 Agustus 2023 - 08 September 2023 |
Digital Activation Officer | Tidak disebutkan | 10 Agustus 2023 - 09 September 2023 |
Territory Manager Area Pekanbaru | Tidak disebutkan | 10 Agustus 2023 - 09 September 2023 |
Campaign Activation Coordinator | Tidak disebutkan | 14 Agustus 2023 - 13 September 2023 |
Technical Project Executive | Tidak disebutkan | 15 Agustus 2023 - 14 September 2023 |
Utility Maintenance Technician | Tidak disebutkan | 23 Agustus 2023 - 22 September 2023 |
Medical Representative - Jakarta | Tidak disebutkan | 24 Agustus 2023 - 23 September 2023 |
Medical Representative Palu | Tidak disebutkan | 24 Agustus 2023 - 23 September 2023 |
Product Quality Assurance Supervisor | Tidak disebutkan | 24 Agustus 2023 - 23 September 2023 |
Product Release Officer | Tidak disebutkan | 24 Agustus 2023 - 23 September 2023 |
Product Release Senior Officer | Tidak disebutkan | 29 Agustus 2023 - 28 September 2023 |
IT Infrastructure Specialist | Tidak disebutkan | 29 Agustus 2023 - 28 September 2023 |
Change & Documentation Supervisor | Tidak disebutkan | 30 Agustus 2023 - 29 September 2023 |
Change Management Officer | Tidak disebutkan | 31 Agustus 2023 - 29 September 2023 |
Customer Interaction Executive | Tidak disebutkan | 04 September 2023 - 04 Oktober 2023 |
Key Account Manager Crop Science - South East Asia | Tidak disebutkan | 07 September 2023 - 07 Oktober 2023 |
Foundation Seed Territory Manager | Tidak disebutkan | 11 September 2023 - 11 Oktober 2023 |
Territory Production Manager Corn | Tidak disebutkan | 11 September 2023 - 10 Oktober 2023 |
Channel Development Lead Crop Science - Indonesia & Malaysia | Tidak disebutkan | 11 September 2023 - 11 Oktober 2023 |
Field Production Coordinator Corn | Tidak disebutkan | 11 September 2023 - 10 Oktober 2023 |
Field Training Manager - Pharmaceutical | Tidak disebutkan | 13 September 2023 - 13 Oktober 2023 |
Production Supervisor | Tidak disebutkan | 01 November 2023 - 01 Desember 2023 |
Production Operator | Tidak disebutkan | 08 November 2023 - 08 Desember 2023 |