Executive/Sr. Executive/Asst Manager - Regulatory Affairs

Job Description

Unison Pharmaceuticals, one of the fastest growing organization is looking for Multiple positions in Regulatory Affairs - Europe/ regulated Market for pre-submission and post-submission. Roles and Responsibilities Ensure timely authoring and submission of dossiers (Module 2-5) for regulated regions such as Europe, Australia, South Africa, New Zealand and Canada in the eCTD format including familiarity with publishing activities. Preparation and submission of documentation for post-approval applications (CMC and Administrative changes) such as Type IA/ IB/ II variations for Europe/UK, Level I/II/III changes for Health Canada, Renewals, and MAH Transfers. Work with submission teams and provide appropriate support for managing the lifecycle of product submissions, and authorizations. Assessment of change controls, defining the correct variation code and preparation of the variation packages as per the agreed timelines. Preparation of quality responses to the deficiency letters from various Clients/agencies within agreed time frame. Co-ordinate with various departments to obtain essential scientific data and documents required for dossier preparation and query responses. Evaluates proposed manufacturing and quality changes for impact to ongoing and existing filings and provides strategic regulatory support for optimal implementation of changes. Involve in review of source documents for in-house: product development report, specification (excipients, API and finished product), manufacturing batch record, analytical method, validation report, validation protocol etc. Actively participate in the evaluation of regulatory compliance of document/product/ process/test methods changes. Provide regulatory insights and support for contract manufacturing projects (CMO/CDMO). Preform gap analysis for extension of dossier to other territories as per country specific requirements. Identifies and communicates risks and issues impacting project progression. Assist in the development of Regulatory CMC strategies for assigned products and projects. Ensure product compliance with respect to approvals and regulatory requirements. Tracker Management: Update/Maintenance of database with regulatory submission and approval. Candidate(s) having previous exposure in EU dossier authoring, product life cycle management/variation and Health Canada filings are preferable. Core competencies: Strong technical understanding of ICH/EU/ANZ/Health Canada guidance's, time management skills, right first time approach, work with minimal supervision. Strong written and verbal communication skills. Interested candidates can share your resume on krupagohil@unisonpharmaceuticals.com