General Manager

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