Assistant Manager, Regulatory Affairs

• 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.

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