Assistant Manager, Regulatory Affairs - Injectable

Job Summary

Compilation and Review of New Product Applications, Product Life Cycle Management (PLCM) submisisons, eCTD compilation and addressing deficiencies of Injectables for various markets like US and Canada

Job Responsibilities

• Review and compilation of Sections/Modules for new product submissions i.e., ANDAs, NDAs and ANDS
• Addressing deficiencies received for new product submissions of Co-development projects (Injectables/Sterile drug products).
• Review of all technical documents required for compiling the post approval submissions (PAS, CBE-30, CBE and sANDS) and query responses.
• Review and finalization of Sterility Assurance Package for Injectables/Sterile drug products
• Review/assessment of change controls which are received from CROs/CMOs
• Review of Drug Master Files/Active master Files/CEPs in relation to New Product Submissions/ Post Approval Submissions
• Relevant communication and follow ups with the respective customers/stake holder required for compilation, submission and respective query responses.
• Responsible for eCTD/RIMS activities of co-development submissions
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• Demonstrate winning behaviours - Individual Accountability, Rigor & Discipline and Continuous improvement in day-to-day activities.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Pharm/B.Pharm/M.Sc./B.Sc.
• Knowledge, Skills and Abilities
  • Sound understanding regulatory affairs submissions.
  • Steriltiy Assurance Package for Injectables
  • Expertise in product life cycle management.
  • People management skills.
  • Ability to learn and adapt quickly.
  • Ability to manage full workload across multiple projects.
  • Excellent verbal and written communication skills
• Experience
  • 8 to 10 years of experience in Regulatory Affairs activities which muct include 3 to 4 years of experience in team/people management