Regulatory Associate - Dossier
Navitas
Chennai India
10d ago

Category : Experienced (non-manager) Location : Chennai

Education : Life Science Graduates

Job Description :

  • Responsible for the review and finalization of Global Regulatory Strategy Documents, CTD sections for IND, CTA, BLA, NDA and ANDA submissions and ensures effective data presentation as per guidance.
  • Responsible for effective coordination with the cross functional teams, site and Global RA teams for authoring, review and finalization of dossiers for the pipeline products to ensure effective data presentation and quality.
  • Prepare quality dossiers for pipeline molecules and supplements to support product launch.
  • Monitor and set timelines for filling MA transfer, variations, license renewals, product amendments / supplements and other product life cycle management activities like annual report and safety report filling etc.
  • Collaborate with company’s global and other regional regulatory team to author quality regulatory submissions for the pipeline products.
  • Reviews health authority queries and co-ordinate global strategy for response.
  • Provides adequate support (respond to deficiency letters) to company’s' global and other regional regulatory team for securing timely approval of regulatory submissions.
  • Provide regulatory support to team, participate and provide regulatory advice in technical review.
  • Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
  • Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management and core team.
  • Keep up to date with international legislation, guidelines ad customer practices in all countries that the company is exporting its products.
  • Undertakes and manage regulatory inspections
  • Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.
  • Responsible for ensuring compliance to Company's submission standards, policies and procedures.
  • Preferred Skills :

  • 2 to 4 years’ experience working in a regulated, life science environment
  • Significant 'Hands on' registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products);
  • preferably from the perspective of a CMC writing and authoring, review and approval of labelling documents.

  • Proven ability to successfully understand regulatory implications of product strategy with regard to the produce label, assessment and practical management of associated impacts.
  • Demonstrated ability to interpret and apply regional / local regulatory guidance for CMC and safety related filling in the pre-
  • approval and post approval (maintenance) stages

  • Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
  • Knowledge of global / regional regulatory guidelines and requirements important
  • Proven strength in logical, analytical and writing ability essential
  • EU and APAC dossier management
  • EU and APAC dossier management or CMC expertise
  • If you would like to apply for this position, or would like a discussion about this, or any other role, please send your contact details, together with your curriculum vitae to :

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