Research and Development Director

1 day ago


Hyderabad, Telangana, India Lee Pharma Limited Full time

At Lee Pharma Limited, we are seeking a highly skilled R&D Head to join our team. This is an exciting opportunity for a seasoned professional to lead our research and development efforts.

The successful candidate will have a strong background in regulatory affairs and be able to manage multiple stakeholders at various levels inside and outside the organization. They will be responsible for ensuring compliance with regulatory requirements for various markets, including US, JP, EDQM, Health Canada, WHO, Domestic, ROW, China & EU.

We estimate the salary for this position to be around $120,000 - $180,000 per annum, depending on experience and qualifications.

Key Responsibilities:

  • Developing processes considering ICH guidelines, GMP requirements, and post-approval changes
  • Problem-solving skills for control of impurities, scale-up process without deviation, achieving polymorph requirements, and Particle Size Distribution (PSD) requirements
  • Excellent negotiation skills and ability to deal with ambiguity and provide clarity to the team members/business partners
  • Dedication to work to achieve long-term/short-term proposed KRA without failure
  • Strong collaborative skills and ability to work with cross-functional teams

Requirements:

  • Bachelor's or Master's degree in a relevant field
  • Minimum 8 years of experience in R&D, Regulatory Affairs, or a related field
  • Proven track record of leading cross-functional teams and managing multiple stakeholders
  • Strong knowledge of regulatory requirements for various markets


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