Project Management Specialist Full Time

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.