Job Title: General Manager (GM) – Project Management
Industry: Pharmaceutical
Location: Remote: Ahmedabad, Gujarat
Reporting To: CSO, Chief Scientific Officer
Position Overview
The General Manager – Project Management will lead the end-to-end project management function for pharmaceutical product development and global regulatory submissions, with specific responsibility for dossiers submitted to Rest of World (ROW) markets.
This role will ensure seamless cross-functional coordination to achieve timely preparation and submission of high-quality dossiers (CTD/eCTD format), maintain governance through stage-gate processes, secure budget approvals, and drive execution excellence across the product lifecycle. The GM will act as a central integrator across Regulatory Affairs, R&D, Analytical Development, Manufacturing, Quality, Supply Chain, Pharmacovigilance, and Commercial teams.
Key Roles & Responsibilities
1. Global Regulatory Submission Oversight
Lead integrated project plans to ensure timely submission of dossiers to:
Health Canada
European Medicines Agency
Relevant regulatory authorities across ROW markets (e.g., MHRA, TGA, GCC, ASEAN, LATAM, Africa).
Oversee preparation of CTD/eCTD modules (Modules 1–5) in alignment with regional requirements.
Ensure readiness for deficiency responses, variations, renewals, and lifecycle management activities.
Monitor submission timelines, review cycles, and regulatory commitments.
2. Cross-Functional Program Leadership
Coordinate closely with:
Regulatory Affairs
Formulation & Analytical R&D
Quality Assurance & Quality Control
Manufacturing & Technology Transfer
Supply Chain & Procurement
Pharmacovigilance
Finance & Commercial
Drive alignment on critical path activities including BE studies, stability studies, validation batches, and site readiness.
Resolve cross-functional bottlenecks impacting submission timelines.
3. Stage-Gate & Governance Management
Implement and manage a structured stage-gate framework from product selection through commercialization.
Schedule and lead gate review meetings with senior leadership.
Ensure projects meet predefined technical, regulatory, and financial criteria before advancement.
Maintain governance documentation and decision logs.
4. Budget Planning & Financial Oversight
Develop and consolidate project budgets covering R&D, bioequivalence studies, regulatory fees, manufacturing scale-up, and launch readiness.
Obtain management approvals and ensure financial discipline.
Track actual vs. planned spend and provide variance analysis.
5. Portfolio & Resource Management
Oversee a portfolio of ANDA/NDS/MAA or equivalent submissions across Canada, EU, and ROW.
Prioritize projects based on strategic, commercial, and regulatory considerations.
Optimize allocation of technical and regulatory resources.
6. Team Leadership & Capability Development
Build and lead a high-performing project management team.
Establish standardized project management tools, dashboards, and reporting mechanisms.
Mentor project managers and develop succession pipelines.
Foster a culture of accountability, compliance, and execution excellence.
7. Risk & Compliance Management
Identify regulatory, technical, and supply risks early in the development cycle.
Implement mitigation strategies to avoid submission delays or deficiencies.
Ensure adherence to ICH guidelines, GMP standards, and regional regulatory requirements.
8. Executive Reporting & Stakeholder Communication
Provide regular portfolio updates to executive leadership.
Present risk assessments, milestone progress, and financial summaries.
Support due diligence, partner discussions, and regulatory inspections as needed.
Qualifications & Experience
Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field.
15+ years of experience in pharmaceutical project/program management.
Proven experience managing submissions to Canada, EU, and ROW markets.
Strong understanding of CTD/eCTD structure and ICH guidelines.
Demonstrated leadership of cross-functional pharmaceutical development teams.
Key Competencies
Deep knowledge of global regulatory pathways (Canada, EU, ROW)
Strategic portfolio management
Financial acumen in pharma development budgets
Strong governance & stage-gate expertise
Advanced stakeholder management
Risk mitigation and compliance orientation
High-level negotiation and influencing skills
BPharm or Mpharm
