Deputy Manager/Manager- CMCRA

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
• Minimum 10-16 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.

Skills and Capabilities

• Excellent English written and verbal communication skills
• Cultural awareness
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Proficiency with common project management (e.g., MS Project) and document management tools
• Ability to work independently and as part of a team
• Influencing and collaborator management skills
• Ability to analyse problems and recommend actions
• Continuous Improvement and knowledge sharing focused
• Operations/Manufacturing organisation (CMC post approval)
• Marketing Companies/Local affiliates

Reporting Relationship

• Direct Reports – 2-4