regional product chemistry project manager in Singapore

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job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
reference number
91M0127169_1540808122
contact
jin quan jonathan soh, randstad
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job description

The Regional Product Chemistry Project Manager (RPCPM) is the product chemistry expert for the Asia Pacific Region. RPCPM works with their Global Product Chemistry Project Managers (GPCPM) to implement the regional product chemistry regulatory strategy. The RPCPM is responsible for the understanding and interpretation of the countries regulatory requirements in the region, proposing study plans to meet those requirements, and accountable for oversight of the studies within their scope. The RPCPM collaborates with local, regional regulatory leaders and assists in project and product chemistry study planning for new product launches, existing registration maintenance, as well as creation of documentation to support regional registration activities (ex. CoC’s, CoA’s, dossiers).



Responsibilities:

Planning and Oversight of the completion of regional and country specific analytical studies and documentation required for:

  • Registration or re-registration of Active Ingredients (AI) and End Use Products
  • Actives & Intermediates Synthesis projects
  • Pipeline Molecules
  • Regulatory Inquiries
  • Manufacturing support (method transfer support, new impurity strategy, specifications)
  • Coordination of local studies with contract labs; physical properties, analytical methods, analysis of material, batch analysis of active ingredients and formulated products are resourced and completed. This will entail protocol writing, managing and reporting of analytical studies in support of product registration and studies to be loaded into Submission Center.
  • Initiating, coordination, formatting requirements (translation of studies to local language, if needed), and issuing product chemistry summaries, reports, and dossiers in support of the registration or re-registration of new ore existing active ingredients and EUP’s.
  • Creating Certificate of Composition (CoC) or Certificate of Analysis (CoA) that are unique to the country or region for registration support.

Communication and partnership with

  • CP PD&P R&D, Product Chemistry, and GLP stakeholders regarding changes to standard, impurities, studies, registration and analytical limitations due to AI, degredates, metabolites, co-formulants, solvents, etc.
  • Business partner and Regulatory Management regarding priority of studies and capacity constraints due to unplanned work or resources.
  • Regulatory manager to understand registration deadlines, regional/country requirements, and regulatory needs in the budgeting cycle (note: Global Product Chemistry Manager is the main communicator with the regulatory manager for the molecule)
  • Influencing within Industry and local partners on regulatory requirements, responding to questions from the authorities, or providing input on change within the product chemistry regulatory environment. In addition to implementing and communicating any new changes to key stakeholders and work processes.
  • Responding to authorities questions promptly, and communicate with global product chemistry project manager if assistance is needed.
  • Providing task and budgeting information to the Global Product Chemistry Project Managers (GPCPM) based on their knowledge of the regional requirements and regulatory timeline.

Educational Requirements:

  • Ph.D. in Analytical Chemistry, Organic Chemistry, Material Science or related field. Candidates without a Ph.D. degree but a minimum of 5 years’ experience in in one or more of the following areas: product chemistry regulatory guidelines, GLP study director, crop protection operations/manufacturing, quality assurance and quality control.
  • Fluency in English is a must for this position



skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree