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
Division: Consumer Health Location: Jakarta Head Office
Functional Area: Regulatory Affairs Position Grade: R13
Employment Type: Regular Work Time: Flexi Hours - 8 working hours
Contact Us
Address Telephone E-Mail
PT Bayer Indonesia
Menara Astra, 33rd floor
Jl. Jend. Sudirman Kav.5-6, Jakarta 10220, Indonesia
+622130491111 recruitment.indonesia@bayer.com
Bayer