Career Opportunities Manager for SPPM

6 days ago

Hyderabad, Telangana, India beBeeregulatory Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

We are looking for a seasoned Regulatory Affairs Manager to lead our team in the Submission Process, Planning, and Management (SPPM) division. The ideal candidate will have a proven track record of driving process improvement and ensuring awareness across the organization.

Key Responsibilities:

  • Develop, maintain, improve, and drive consistency across CMC processes
  • Facilitate communication across teams to ensure process robustness and awareness
  • Drive consistency across teams
  • Develop and maintain training materials
  • Train staff on select departmental processes and procedures
  • Ensure consistent use of processes and tools across teams
  • Continuous improvement of templates for presentations, timelines, trackers, and other tools
  • Liaise with functions in GRAAS and Operations to ensure alignment
  • Participate in cross-functional special project teams
  • Potential to oversee or manage staff

Requirements:

  • Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Master's/ Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor's degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
  • Bachelor's degree or higher in Life Sciences, Engineering, or a related field
  • Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry
  • Working knowledge of Regulatory CMC processes and global submission requirements
  • Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs
  • Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms)
  • Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus

Desirable Skills:

  • Strong project management and organizational skills with the ability to manage multiple priorities
  • Excellent written and verbal communication skills, with experience presenting to diverse audiences
  • Demonstrated ability to collaborate across global, cross-functional, or matrixed teams
  • Experience supporting onboarding, training, or continuous improvement initiatives
  • Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency

A career at our company means being part of a collaborative team that strives to serve patients worldwide. We value diversity, innovation, and continuous improvement.

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