Project Planning & Execution:
- Drive cross-functional planning for assigned R&D projects from development to submission.
- Prepare and manage project timelines, risk registers, and mitigation plans.
- Ensure timely execution and closure of development milestones.
Portfolio Management:
- Maintain and update R&D portfolio database.
- Track progress of all projects against development and filing timelines.
- Assist in portfolio prioritization based on business, technical, and regulatory complexity.
Cross-Functional Coordination:
- Liaise with Formulation, ADL, Regulatory Affairs, IPR, Supply Chain, BD, and Commercial teams.
- Facilitate communication between cross-functional teams and resolve bottlenecks.
Stakeholder Communication:
- Prepare and present project updates to senior management and governance committees.
- Support leadership reviews, internal audits, and regulatory inspections with relevant documentation.
Documentation & Reporting:
- Maintain accurate and timely project records, trackers, and dashboards.
- Generate reports for internal stakeholders, including weekly/monthly status reports.
Process Improvement:
- Contribute to continuous improvement initiatives within project management systems and processes.
- Implement project governance tools to improve project visibility and predictability.
- Education: M.Pharm / B.Pharm in Pharmaceutical Sciences or related discipline.
- Preferred Background:
- Experience with US/EU generics; understanding of formulation development, regulatory filings (ANDA, Dossiers), and technology transfers.
- Prior experience in managing ANDA/ANADA/MAA development projects or regulatory lifecycle projects is preferred
- Skills and Key Attributes:
- Strong project management, communication, and stakeholder management skills.
- Proficiency in MS Project, Excel, PowerPoint, and other PM tools.
- Working knowledge of pharmaceutical R&D workflows.
- Analytical thinking, problem-solving ability, and cross-functional leadership.
- Detail-oriented and organized, Strong sense of ownership and accountability.
- Ability to manage multiple projects and adhering to the timelines
- Team player with a proactive and collaborative approach.
