Strong knowledge about the regulatory
guidance for product development activity up to dossier submission for Regulated
market (Europe).
Expertise in handling of the Regulatory
queries at different stages of approval in co-ordination with all cross
functional team as per requirement.
Expertise in designing of the Regulatory
submission strategy at initial stage of the development activity.
Review of all
documents from plant/R&D/CRO as required for dossier submission for all
Regulatory market.
Co-ordination with Regulatory
Agent/Submission Partner(s) for Submissions to Regulatory Authority.
Awareness of
Regulatory submission pathway & costing for Dossier submission to
Regulated market.
Responsible for
overall Regulatory Department Budget Preparation activity.
Preparation of eCTD
Compilation, Validation and Publishing of Dossier in Software and filling
with the Authority as per management decision
Always updates on the
recent requirements & expectation in terms of Regulatory guidance from
Regulatory market drug product submission activity.
Preparation and
Submission of the regulatory submissions for Controlled Correspondence,
Suitability Petition etc. for Regulatory market as per requirement.
Awareness about the Licensing activity
& Logistics for the Regulatory submission activity.
