Regional Regulatory Affairs Manager Asia Pacific

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

  • Responsible for developing and implementing sound regulatory strategies and risk mitigation plans for assigned portfolio and assigned AP region, alignment of these with business plans and business strategies
  • Maintain full awareness of all regulatory activities of assigned portfolio/ AP region  and work closely with headquarter and country teams (not limited to RA alone) to ensure project deadlines, performance and compliance standards for assigned portfolio/ AP region are established and met throughout a drug’s entire life cycle
  • Work closely with country RA to monitor and track updates and changes in the regulatory environment in the AP region, including competitor intelligence gathering, and share this timely with headquarters and regional stakeholders
  • Act as regulatory expert to global/ regional stakeholders on regulations, guidelines interpretation within the region
  • Participate and support roll out of regulatory compliance activities for assigned portfolio/ AP region according to local regulatory requirements and to internal standards (eg. OIs, SOPs). Provide input into internal standards development as needed
  • Regularly prepare and present concise status updates of assigned portfolio/ AP region to regional/ global stakeholders as required
  • Participate in industry association’s forums to establish networks and look for opportunities to shape regulatory framework in alignment with the company’s policy direction and business objectives, as needed

Requirements

  • Possess a Life Sciences degree with minimum 5 to 7 years of pharmaceutical industry experience ideally spanning across full development spectrum with a proven track of managing complex regulatory applications to successful outcomes across various types of applications (eg. IND, NDA) and across various areas
  • Has in-depth technical regulatory knowledge in at least one therapeutic area or technical area (CMC, clinical), and demonstrated thorough understanding of local regulatory requirements for countries in the AP region
  • Capable in recognizing business needs, think strategically and develop risk mitigation strategies
  • Fluent in English both oral and written with knowledge in additional Asian language skills beneficial and able to communicate effectively in English to convey (complex) technical information to regional/ global area experts and be able to discuss/ present expert matters confidently
  • Possess good understanding of regional diversity and cultures gained from having worked in AP region or other emerging markets
  • Possess strong leadership and interpersonal skills to:
    • interact with highly culturally diverse team remotely, to effectively support APAC business goals
    • Handle complexity and ambiguity and closely work with country RA team and other stakeholders as business partner to achieve business goals
    • Chair internal cross-functional task forces when needed
  • Possess a structured approach to working tasks and problem solving and able to manage projects independently within time constrained situations
  • Possess good interpersonal and communication skills to facilitate the ability to negotiate and influence others, while dealing with issues which have considerable scientific and regulatory uncertainty
  • Has the analytical capability to evaluate complex  ambiguous situations and to proactively identify potential issues and future trends and to translate into business cases
  • Has learning agility and able to quickly adapt to new situations
  • Has thorough knowledge of company policies and procedures related to drug development and regulatory maintenance activities

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