Executive/Sr. Executive/Asst Manager - Regulatory Affairs

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