Consultant, Regulatory Affairs

1 day ago

Singapore IQVIA Full time

This is a go-to-market role with governance oversight of delivery and relationship ownership over the entire client engagements for various regulatory offerings to pharmaceutical, medical devices & diagnostics and consumer health prospects and clients. You will collaborate with on/offshore, multi-functional teams in a matrixed set up, manage multiple projects of varying complexity, ensure on-time and on-budget delivery and partner with sales & business development teams to strengthen client base.

**Responsibilities**

As a Consultant at IQVIA, you will provide Subject Matter Expertise and Guidance in all aspects of regulatory services such as Pharma products, Vaccines, OTCs, Medical Device, In Vitro Diagnostic (IVD), Artificial Intelligence Medical Device, Standalone medical device software submissions etc.
- Understand clinical aspects for bridging study evaluations and clinical assessment.
- Assume primary or secondary regulatory responsibility for assigned projects by providing the project team with regulatory information, guidance, training, support and strategic planning based on applicable regulations issued by the regulatory agencies across JAPAC.
- Deliver on regulatory projects in a timely and proactive manner. Manage projects by coordinating with in-country regulatory team leads.
- Identify and interpret regulations, guidelines, and other pertinent information issued by the applicable regulatory agencies and other regulatory organizations.
- Review scientific data, publications, and related papers, as appropriate for various regulatory projects to ensure compliance with regulations. (Strategic guidance, dossiers preparation, submission activities & etc.)
- Develop effective product registration strategies by performing critical review and gap analysis of product documentation.
- Establish relationships with regulatory agencies, health bodies, internal and external stakeholders; may meet face to face to discuss regulatory issues. Adopt a proactive and flexible approach to resolve any issues.
- Undertake detailed review and management of budgets related to projects, including out of scope activities.
- Ensure revenue is recognized by managing professional activities and internal stakeholders’ finances allocation.
- Deliver training workshops and regulatory webinar to internal and external stakeholders.
- Assist in identifying business opportunities for regulatory projects.

**Skills & Experience**
- Bachelor's degree with at least 6 years of related work experience in regulatory affairs. (Medical device / in-vitro diagnostic registration experience a plus)
- Demonstrate comprehensive regulatory affairs expertise. aptitude for activities related to regulatory affairs and quality compliance for products market access and maintenance.
- Familiarity with regulatory documents, general contents and the methods of filing and tracking.
- Good interpersonal and negotiating skills, with an ability to identify and resolve issues efficiently and effectively.
- Ability to read/synthesize technical materials and prepare clear/concise written documents.
- Ability to juggle competing priorities to meet deadlines while maintaining high quality work.

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