Regional RA Manager CC APAC

Permanent Position
01 Jun 2017
Expires on 15 Jun 2017

Company Description

A global enterprise with core competencies in the Life Science fields of healthcare and agriculture. Its products and services are designed to benefit people and improve their quality of life. Our client is the global in-house consulting arm, providing high-end management consulting services exclusively to senior decision-makers across all worldwide.

Posted by

Hong Andi (Reg No: R1658099)

Tel

+65 6738 6188

Email

Job Description

  • Support the GRA CC Regional Head in coordinating all  regulatory activities amongst the countries in the AP-Japan region for the CC product portfolio; all aspects related to regional in-license projects, including but not limited to due diligence, project planning and execution; and, as needed, in developing strategies for business growth or protection activities by coordinating the regional strategy development in alignment with local RA colleagues
  • Identify potential training needs for product categories covered in CC portfolio and arranges internal training options to develop LRAMs
  • Ensure implementation of global labeling processes, variation processes, adherence to global SOPs and communication strategy
  • Ensure appropriate know-how on regional regulatory issues, regulations and interpretation of guidelines within the region and provides expert leadership to the key functions for covered projects and areas, including collection and impact analysis of regulatory intelligence
  • Responsible for ensuring regulatory compliance for the assigned product portfolio in the region according to local regulatory requirements and to internal requirements (e.g. SOPs) together with the GRA CC Regional Head
  • Collaborate closely and align with CC Global Strategy and Infrastructure functions in defining and assessing roll-out strategies
  • Proactively identify regulatory issues/risks and coordinate the development and execution of mitigation plans
  • Participate, as needed, in industry association groups to create an effective network as well as proactively influencing the direction of regulatory policy in alignment with CC business objectives

Requirements

  • Possess Ph.D., or M.D. or scientific degree with a minimum of 6 years of regulatory experience preferably in consumer care setting
  • Fluent in English, fluency of a local language of the region is a plus
  • Possess excellent oral and written communication skills
  • Possess strong leadership skills and able to demonstrate cross-functional communication, interpersonal, influence, and negotiations skills
  • Able to focus on multiple issues concurrently, with the ability to organize and direct diverse activities in a changing environment often under time pressure
  • Sensitive to the diverse cultures comprising the International and Global Regulatory Environment
  • Possess solid knowledge of international (ICH, WHO) and national/regional regulations and guidance documents
  • Able to develop effective solutions to diverse and complex business problems
  • Possess scientific and technical expertise including the ability to develop and oversee robust regulatory plans
  • Strong analytical regulatory skills and attention to details

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