Primary Function/Primary Goals/Objectives of Abbott

  • Develop and execute regulatory assessments to ensure successful registration and approval of products in India by:
  • Analyzing and identifying regulatory requirements against project needs
  • Communicating registration needs prior to and during product development
  • Preparing options, suggestions, and/or a regulatory assessment for product registration to achieve Affiliate project goals
  • Execute plans, complete tasks according to priorities, align work with business goals, and align actions with agreed strategies.
  • Excellent communication skills and ability to effectively present scientific data both in writing and verbally to management.

Roles & Responsibilities

  • Responsible for portfolio across 3 Business Units
  • Review and maintain regulatory documents and files (including product label, promotional materials, manufacturing change requests, and registration packages); record product filings, approvals, and registration activities.
  • Coordinating regulatory activities including development, presentation, and review of required regulatory documents in support of product registrations
  • Ensure requirements for effective approvals and registrations are met in a timely matter.
  • Support submission/filing projects and implement strategies to address issues throughout the filing process.
  • Prepare registration packages in line with local regulatory requirements and guidelines.
  • Participate in and contribute to decisions in cross-divisional team meetings; participate in preparing regulatory strategies.
  • Establish strong connections with regulators and industry associations/standards to gain insights on upcoming changes of regulations
  • Represent Abbott in industry associations/standards committees to ensure the industry standards is favourable to company’s products
  • Gather regulatory intelligence that is relevant to Abbott portfolio and disseminate as appropriate
  • Maintain close relationship with government authorities and test institutes

Accountability/Scope

  • Responsible for tracking and timely completion of registration activities assigned.
  • Ability to influence the development of a new product in line with regulatory requirements.
  • Completion of registration packages, completion of document review/approval, and product label material review as per project time-line.
  • Accountable to APAC Regulatory Affairs Head. Dotted line reporting to India County manager
Required Skills, Education & Experience
Education:

Bachelor’s/Master’s Degree in Engineering, medical/biomedical background or other science related field

Background:

10- 12 years in regulatory affairs in Medical Devices, ideally in IVDs. 

Experience in working in a multi-function team environment

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