**Chemistry Manufacturing Control Documentation Manager****JOB PURPOSE**- Regulatory CMC Documentation Manager, leads and manages all aspects of the Chemistry, Manufacturing and Control (CMC) documentation organization. The CMCD Manager provides technical leadership for the registration of new products and lifecycle management of products within ASEAN, by developing and coordinating technical dossier strategies and activities to ensure timely approval and product compliance. All is done in accordance to Bayer global procedures and to local regulatory agencies, to ensure business continuity of products and registration of new products within ASEAN.**YOUR TASKS AND RESPONSIBILITIES**New products (Business growth)- As the technical regulatory expert, provides strategic technical leadership at the early stage of the LPPM process to ensure technical dossier approval by Health Authorities (HA) across ASEAN and other regions.- Timely develop high quality technical dossier for new product submissions.Commercial products (Business continuity)- Provide regulatory strategy suggestions for crucial change controls and provide technical regulatory input on related risk/impact on approved dossiers- On-time development of high quality technical and CMC documents for variation submissions.- Develop scientific and technical justifications for the timely and accurate assembly of responses to inquiries from Regulatory agencies on CMC content of regulatory submissions.- Develops the strategy for the preparation of the technical documents to support Site Transfers taking into consideration the documents available in the manufacturing site and the specific regulatory requirements.- Partner and coordinate activities with multiple functions (Local Regulatory Affairs, Manufacturing site) to ensure the timely technical compliance of dossier, when new legislation is implemented.General- Manage workload to ensure deliverables and internal compliance metrics are achieved. Develop, maintain, and report quality metrics to Key Tasks: management.- Provide technical advice to corrective actions or recommendations that would ensure a compliant dossier.- Ensure coherence of current practices related to potential new regulations in countries w/in ASEAN and communicate these relevant changes that might impact the manufacturing sites.- Collaborates and partners with other regulatory stakeholders (Regulatory Project Leads, Local Regulatory Affairs, Global Regulatory Function) to ensure compliance of the technical documentation according to valid legislation.- Coordinate with Product Supply (Global/Local) and Manufacturing sites for change controls, specifically for those changes where there is limited bridging stock.**WHO YOU ARE**- Bachelor's degree in Life Sciences (Pharmacy, Chemistry, Biology)- At least 3 to 5 years of experience in CMC documentation for ASEAN/APAC and at least 5 years' experience in the pharmaceutical industry (knowledge of pharmaceutical development, testing or manufacturing processes).- Preferably with current knowledge or experience with the different ASEAN country regulation.- Preferably with experience in handling any of the different CH categories (analgesics, nutritional's, allergy, cough & cold, digestives, dermatology).- Knowledge in international regulations (ICH, FDA, EMA, WHO)- High degree of English fluency (technical and business language), writing, listening and speaking & ability to communicate effectively- Ability to engage and build strong collaborative relationships across multiple functions and levels of leadership- Ability to manage complexity, ambiguity and numerous projects simultaneously- Robust Analytical Skills- Accomplish objectives despite obstacles and setbacks. Pushes self to achieve results- Strong communication, negotiation, and decision-making skills- Demonstrated ability/experience developing and running effective business processes**Application Period**:- 20 June 2023 - 3 July 2023**Reference Code**:- 795016**Division**:- Consumer Health**Location**:- Jakarta Head Office**Functional Area**:- Regulatory Affairs**Position Grade**:- VS 1.1**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
