Senior Formulation Development Project Manager

2 weeks ago

Bikaner, Rajasthan, India beBeeFormulation Full time ₹ 1,80,00,000 - ₹ 2,50,00,000

As a seasoned professional in the field of formulation development, we are seeking an exceptional Senior Formulation Development Project Manager to join our team. The ideal candidate will possess a strong background in managing complex projects from conception to delivery, with a focus on solid oral dosage forms, parenteral dosage forms, liquid dosage forms, and topical dosage forms.

The successful candidate will be responsible for leading cross-functional teams to drive project success, ensuring timely deliverables, and managing budgets and resources effectively. They will also be expected to collaborate closely with stakeholders, including governance boards, to ensure alignment and communication.

Key Responsibilities:

  • Develop and execute project plans, including timelines, milestones, and resource allocation.
  • Foster strong relationships with internal and external partners to achieve project objectives.
  • Maintain up-to-date knowledge of regulatory guidelines, industry trends, and best practices in formulation development.
  • Ensure compliance with quality management systems and good manufacturing practices (GMP).
  • Analyze data and metrics to identify areas for improvement and implement process enhancements.

Required Skills and Qualifications:

  • Master's degree in Pharmacy or related field, with at least 9 years of experience in project management.
  • Proven track record of delivering complex projects on time, within budget, and to required quality standards.
  • Expertise in eCTD dossier modules and regulatory filing pathways for EU, US, CA, PMDA, LATAM, and other regions.
  • Proficiency in Microsoft Excel, PowerPoint, and EPM/MSP software.
  • Familiarity with generic drug development cycles, including 505(B2), complex generics, peptides, and various regulatory guidelines.

Core Competencies:

  • Strategic thinking and problem-solving skills
  • Excellent communication and interpersonal skills
  • Results-driven and customer-focused mindset
  • Ability to work in a dynamic and fast-paced environment

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