This position, Senior Manager in Global Regulatory Affairs LCM-CMC, is a project-facing CMC position supporting life-cycle management.

Key Responsibilities

Regulatory Strategy & Execution

- Develop and implement global regulatory strategies for post-approval CMC changes.
- Assess regulatory impact of manufacturing, process, analytical, and supplier changes.
Provide strategic CMC regulatory guidance to cross-functional teams (Quality, Manufacturing, Supply Chain, Analytical Development).

Submission Management

- Author, review, and manage submission of post-approval regulatory filings, including:
- Variations (Type IA/IB/II)
- Supplements (PAS, CBE-30, CBE-0)
- Annual reports
- Renewals and line extensions

- Ensure alignment with regional requirements (FDA, EMA, & PMDA)
Coordinate timely submission and approval of regulatory documents.

Lifecycle Management

- Manage change control assessments and regulatory categorization.
Maintain regulatory dossiers (Module 3) in line with current regulatory expectations.

Health Authority Interactions

- Serve as a key contact for CMC-related queries from health authorities.
Prepare responses to regulatory questions and deficiency letters.

Cross-Functional & External Collaboration

- Partner with MSAT, ARD, Pharm-Sci, Quality Assurance, Supply Chain, and Commercial

- Participate in change review boards and governance bodies.

- Provide regulatory input on product supply continuity strategies





- Interface and represent GRA with/to external partners to ensure global dossier alignment and support supply and enable the commercial success

Competencies

- Ability to develop global regulatory strategies for post-approval CMC changes
- In-depth understanding of regional frameworks:
- US FDA (BLA lifecycle, supplements categories)
- EU EMA (Variation Regulation)
- Japan PMDA requirements

- Capability to balance compliance, speed, and business needs (e.g., supply continuity)
- Skilled in risk-based decision-making and regulatory scenario analysis
- Solid knowledge of biologics manufacturing processes :

- Cell culture, upstream/downstream processing
- Aseptic filling, sterility assurance

- Understanding of:
- Analytical methods & specifications
- Process validation and control strategies

- Expertise in comparability principles (ICH Q5E)
- Familiarity with ICH guidelines (Q5E, Q6B, Q8–Q12)
- Understanding of:
- Supply chain implications of regulatory decisions
- Commercial priorities and market needs

- Ability to align regulatory strategy with business continuity and product lifecycle value

Qualifications:

- PhD 3+ years, MS 5+ years, BS 7+ years in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent.
- Previous experience in life cycle management activities with direct experience in variation filing for US, EU & Japan
- Subject matter expertise in regulatory affairs and related activities.
- Proven ability to produce high-quality CMC documentation for complex large molecules
- Ability to work in a matrix, teams, and diverse cultures is essential
- Fluency in English is essential

📌 Senior Manager, Regulatory LCM (India)
🏢 Alvotech
📍 India