Senior Manager - Product Development(Injectables)

Role & responsibilities

• Product Strategy & Planning

• Define development strategy for injectable formulations (solutions, suspensions, emulsions, lyophilized products)
• Align product pipeline with regulatory and market needs (US/EU/ROW)

• Formulation & Process Development

• Lead pre-formulation studies, excipient compatibility, and prototype development
• Oversee scale-up, optimization, and validation of manufacturing processes

• Cross-Functional Leadership

• Collaborate with R&D, QA/QC, Regulatory Affairs, and Manufacturing teams
• Manage technology transfer to commercial sites or CROs

• Regulatory & Compliance

• Ensure documentation for ANDA/NDA submissions is complete and compliant
• Support audits and inspections with technical and regulatory expertise

• Project Management

• Develop timelines, allocate resources, and monitor progress across multiple projects
• Mitigate risks and troubleshoot formulation or analytical challenges

• Innovation & Market Intelligence

• Stay updated on novel delivery systems (e.g., liposomes, microspheres, depot injections)
• Benchmark competitors and identify opportunities for differentiation

Preferred candidate profile

Essential Skills & Competencies

-Deep knowledge of injectable dosage forms, aseptic processing, and formulation science

-Familiarity with FDA, EMA, ICH guidelines and dossier preparation

-Ability to lead cross-functional teams and manage timelines effectively

-Skilled in preparing MFRs, BMRs, SOPs, and handling change controls

-Capacity to explore new technologies and delivery platforms

-Strong verbal and written skills for internal coordination and external presentations

-13-18 years of experience in pharmaceutical industry with expertise in injectables product development.

-M.Pharma degree or equivalent qualification (e.g., Ph.D./Doctorate).

-Proven track record of successfully leading complex projects from ideation to execution.

-Strong understanding of global regulations governing pharmaceuticals (e.g., FDA, EMA).