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Manager - Regulatory Services

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Primary Location: Singapore, Singapore Additonal Locations: Kuala Lumpur, Malaysia,MYS Full time R1247953

Job description

BASIC FUNCTIONS:


To provide strategic clinical IND and NDA, clinical protocol synopsis, regulatory information and quality support to projects across key focus areas such as biologics, vaccines, marketed drugs and pharmaceuticals across markets (mainly JAPAC); other areas as medical devices, new medical procedures and OTCs are in some projects coverage. To support regulatory agency interactions, communications, and submissions; and to work with teams in reviewing project regulatory documentation to ensure compliance with applicable regulations and guidelines. Drive regulatory excellence in developing regulatory proposals to maximize client market access investment.

Mandarin speaking to cover China, Taiwan, HongKong, Macao, etc.


ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Assist head of regulatory services in assuming primary or secondary regulatory responsibility for assigned projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agencies across JAPAC.
  • Delivering on regulatory projects in timely, proactive manner to ensure quality support; Managing projects by coordinating with IQVIA in country regulatory team leads. Identify, onboard and engage MAH vendors/ freelancers to develop regulatory proposals and compare price, with supervisor guidance
  • Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations. Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various regulatory projects to ensure compliance with regulations. (i.e. strategic guidance, dossiers preparation and submission activities in teams)
  • Establish relationships with regulatory agencies, health bodies, internal and external stakeholders; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues.
  • Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognized by managing professional activities and internal stakeholders’ finances allocation.
  • Training workshops and regulatory webinar to internal and external stakeholders, as supervised by Regulatory head. Identify business opportunities for regulatory projects
  • Performs other tasks or assignments, as delegated by Regulatory head

KNOWLEDGE, SKILLS AND ABILITIES:

  • Minimum of 5-7 years experience in an APAC/Global Regulatory Affairs role in the pharmaceutical/biotechnology industry (medical device, OTC fields knowledge is a plus)
  • Extensive understanding of clinical requirements (regulatory aspect) for IND and NDA submission to come up with the best strategy to ensure MA approval.
  • Knowledgeable in ICH efficacy guidelines with focus on ICH E5 requirements, bridging study designs and protocols, local clinical trial requirements as well as CMC requirements for IND application across APAC region.
  • Demonstrates comprehensive regulatory or technical area of expertise. aptitude for activities related to regulatory affairs and quality compliance for products market access and maintenance, internationally. Familiarity with regulatory documents, general contents, organization and the methods of filing and tracking.
  • Good interpersonal skills, negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach. Ability to read and synthesize technical material and to prepare clear and concise written documents.
  • Ability to work on several projects, retaining quality and timelines and can prioritise workload with minimal supervision
  • Ability to project manage, and be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
  • Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality maintenance.

MINIMUM RECRUITMENT STANDARDS:

  • Requires Bachelor's degree with at least 5 years of related work experience in regulatory space, focusing on IND and NDA submissions (Pharma products registration success preferred)
  • Excellent analytical and communication skills, particularly writing skills, are essential.
  • Demonstrated regulatory excellence

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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