Regulatory Affairs Manager

Job Description - Deputy Manager, Global Regulatory Affairs

The Deputy Manager, Global Regulatory Affairs will be responsible for supporting and independently managing global regulatory activities for complex injectable products, peptide molecules, GLP-1 receptor agonists, and associated drug-device combination products across development, registration, approval, launch, and post-approval lifecycle stages. The role requires strong understanding of CTD/eCTD submissions, complex generic and peptide regulatory expectations, device-related requirements, CMC documentation, health authority deficiency management, change control assessment, and stringent regulatory authority lifecycle management. The incumbent will work closely with R&D, Manufacturing, QA, QC, Device Development, Clinical/BE, Program Management, Supply Chain, Commercial teams, affiliates, local regulatory partners, and external consultants.

Key Roles & Responsibilities

1. Global Regulatory Submission Management

• Coordinate with QA, QC, R&D, Manufacturing, Analytical Development, Device Development, Clinical/BE, Supply Chain, and other cross-functional stakeholders for timely collection of documents required for global regulatory submissions.

• Review documents received from cross-functional teams for adequacy, completeness, scientific consistency, data integrity, and regulatory compliance before their inclusion in regulatory submissions.

• Review and support preparation of regulatory dossiers in CTD, eCTD, ACTD, and country-specific formats/checklists in accordance with applicable health authority requirements.

• Support submissions covering initial registrations, ANDAs/generic applications, variations, amendments, supplements, renewals, deficiency responses, and post-approval changes.

• Ensure consistency between Module 2 summaries and Module 3 supporting information, particularly for complex products where manufacturing process, analytical controls, specifications, stability, device information, and control strategy are critical.

2. Complex Injectables, Peptides & GLP-1 Regulatory Strategy

• Support regulatory strategy for complex injectable, peptide and GLP-1 products from development through registration and lifecycle management.

• Evaluate product-specific regulatory considerations associated with: o Peptide API characterization and impurity control, Peptide-related impurities and degradation products, Manufacturing process and control strategy, Comparative physicochemical and structural characterization, Critical quality attributes, Analytical method suitability, Stability and in-use stability, Container closure systems, Extractables and leachables, Sterility assurance and microbiological controls, Particulate matter and visible/sub-visible particles, Compatibility with administration devices

• Identify potential regulatory gaps early and work with development and CMC teams to establish appropriate mitigation strategies.

3. Drug-Device Combination Product Regulatory Support

• Support regulatory activities for GLP-1 and peptide products supplied through prefilled syringes, prefilled pens, reusable/multidose pens, autoinjectors, cartridges, or other delivery systems, as applicable.

• Review device-related regulatory documentation such as: o Device description and design documentation, Design verification and validation, Device performance/functionality studies, Dose accuracy and dose delivery, Container closure/device compatibility, Human factors/ usability documentation, Risk management documentation, Device change assessments

• Coordinate with device, quality, engineering, and regulatory teams to ensure alignment between the drug product dossier and device-related regulatory documentation.

4. Health Authority Queries & Deficiency Management

• Define and support strategies for responding effectively to regulatory authority queries and deficiency letters.

• Coordinate responses with relevant SMEs and ensure commitments and response timelines are clearly communicated.

• Critically review health authority responses for scientific accuracy, completeness, consistency with the approved/submitted dossier, and regulatory acceptability.

• Challenge responses or supporting justifications where the available data do not adequately address the authority's concern.

• Track regulatory deficiencies through closure and proactively escalate issues that may impact approval timelines, launch readiness, or supply continuity.

6. Lifecycle Management & Post-Approval Changes

• Review and approve change controls and perform global regulatory impact assessments for assigned products.

• Determine appropriate regulatory filing requirements, implementation pathways, and supporting documentation for post-approval changes.

• Review documentation for variations, supplements, amendments, renewals, annual reporting, and other lifecycle submissions.

• Maintain country-wise impact assessments to ensure changes are implemented only after applicable regulatory requirements are fulfilled. • Support lifecycle strategy for changes involving API, drug product, manufacturing sites, manufacturing processes, analytical methods, specifications, packaging, container closure systems, and devices.

Education & Experience Qualification

• M.Pharm / M.Sc. / Pharm.D. or equivalent postgraduate qualification in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, or a related discipline. Preferred Experience

• Approximately 6 to 10 years of Regulatory Affairs experience, with meaningful exposure to global markets.

• Hands-on experience with complex injectables, peptide products, GLP-1 products, sterile products, and/or drug-device combination products strongly preferred.

• Experience with submissions to major health authorities and markets such as US, EU, UK, Canada, Australia, and other regulated/emerging markets would be advantageous.

• Demonstrated experience in dossier review, health authority queries, change control assessments, lifecycle management, and cross-functional regulatory coordination.