Team Lead Regulatory Strategist/ Specialist

•  Complete Regulatory Support – providing regulatory services/ support for client projects for assigned
  markets.
• Markets assigned could be few or all from the following:
  • Should be well versed with country specific regulations and standards or at least know-how on
  obtaining information from relevant resources/  internal teams or Global/ regional offices.
  • Promptly gathering RA/ RI information from database or resources for projects.
  • Advise and inputs on Regulatory strategy/ Pathway of various products in scope.
  • Devising Regulatory strategy right from the product development to lifecycle management to
  addressing all submission requirements and to comply with the mandatory requirements.
  • Identification of applicable product category/ product classification (Nutraceuticals/Health
  Supplements/ OTC/ Cosmetics)
  • Advising on the given/ specified claims for products ( as a part of claims review) basis claims guidelines
  for the markets.
  • Label review and Formula review ( ingredient assessment) of products in scope.
  • Assessment of current product compliance against registration requirements.
  • Identifying risks and challenges in registration and recommend mitigation approach, alternate route
  • Acting as a subject matter expert for assigned markets/ regions through team collaboration with all
  stakeholders to ensure regulatory deliverables are achieved.
  • Addressing queries from HA (Health authority) within the stipulated timeframe.
  • Promptly acknowledging and suitably addressing regulatory queries and issues within Team / globally,
  resulting utmost resolution.
  • Effective management of resource and timeline – Manage regulatory resource and track registration
  timelines to ensure plans are aligned to commercial objectives
  • Managing the given project independently for delivery and project Management aspects. Delivery
  schedule of projects should be managed efficiently without any delays from team.
• Sharing of information pertaining to latest, updated or New Guidelines/Regulations etc., published by
  the Regulatory Authorities, trade associations, journals, news inorder to keep them abreast of latest
  development and guide the team on the impact, if any, due to the changes in regulatory environment
  and way forward to handle the changes effectively – for the assigned markets
  • Review of all delivery reports of the assigned markets projects.
  • Responding to queries/ requests in timely manner (within team and cross functional teams)
  • Participating in various meetings/ calls of team in India/ globally on behalf of client for given markets
  • Preparing regulatory overview presentations ( as per requirement) for internal team, Global team
  members / clients
  • Training team as and when required , on Consumer RA for specific markets – as and when needed.

• Bachelor’s or Master’s Degree in Science or Pharmacy or Biotechnology with a minimum of 2-4years
of experience in regulatory affairs function ( Pharma, Food and Cosmetics/ Personal care products)
• QA and compliance knowledge and experience, would be an added advantage but not mandatory
• Global exposure to various projects for regulatory support …countries like USA, EU, Canada, India, UK,
ANZ, SE Asean markets will be an added advantage.