Manager CMCRA - Pune, India - Enzene Biosciences Ltd

Description

Job Description: Accountabilities/Responsibilities:

Regulatory Affairs Management-

· Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets.

· Provides regulatory input on procedural and documentation requirements as defined by Health Authorities such as Indian regulatory authority, Emerging markets and ROW countries.

· Review of documents (e.g. RCGM-PCS, CTA, MAA, PAC, response documents, study protocols, regulatory maintenance documents, PSURs, etc.).

· Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.

· Uses and shares best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.

· Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions.

· Liaises closely with cross-functional members with aligned product responsibilities.

· Develops, completes and maintains submission delivery plans, submission content plans, and proactively provides status updates of the ongoing projects within the organization.

· Coordinates the input, maintenance and revision in the project planning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to function head.

· Supports operational team and Project team w.r.t to regulatory requirements.

· Provides coaching, mentoring and knowledge sharing within the team.

· Contributes to process improvement.

Minimum Requirements –Education and Experience

· Relevant University Degree in Science or related field with 14+ years of relevant Regulatory experience within the biopharmaceutical industry, including experience in CTA, MAA, PAC and ROW markets for Biological and Biosimilar products and general knowledge of drug development

· Good knowledge of the regulatory product maintenance process

· Strong project management skills

· Leadership skills, including experience leading multi-disciplinary project teams.

Preferred Experience

· Regulatory affairs experience across a broad range of markets.

· Having experience in Regulatory information management system

· Handled regulatory deliverables at the project level

· Experience of working with people from locations outside of India, for Emerging and ROW markets.