Team Leader - CDT

Division

Department

Employment Type

Job Purpose

Designing the strategy for the registration of API globally and implementing the strategy by working with team members and cross function team, to ensure timely and quality Regulatory submission of APIs.

Accountabilities

• Provide the regulatory / scientific guidance for compilation of strategy during development of the API to achieve regulatory compliance in coordination with HOD.
• Prepare the plan for compilation of DMF for on time submission to customers and agencies. 
• Provide the regulatory/ scientific guidance for responding the DMF deficiencies from customer and agency and evaluate the responses to achieve on time approval. 
• Assess the regulatory strategy for post approval changes and gap assessment done for launch.
• Analyze and provide guidance for the quality submission of API for our key ANDA submission / Launch projects. Review and guide outsource Intermediate for compilation of DMF documents/ quality response to deficiency.
• To give relevant training to my team on Regulatory guidance and intelligence, in order to upskill the team and build awareness on best practices.

Education Qualification

M. Sc./M. Pharm & Having a PhD in Chemistry is considered advantage

Relevant Work Experience

10 - 15 years of experience in Regulatory Affairs15-20 years of experience in Pharma industry, about 10 to 14 years of experience in API Regulatory Affairs and 5-7 years of managing teams for filing, maintenance, deficiency management and post approval changes.

Competencies/Skills

Job Location

Vikhroli

Shift Hours