Regulatory Manager

Requirement

Experience in API Regulatory Affairs

Routine job skill:

• Good conceptual, analytical, problem solving, reasoning and organizational skills.
• Should be change agile and have ability to work in highly matrixed environment.
• Attention to detail and accuracy required.
• Must be able to prioritize with independently/minimal guidance.
• Ability to handle multiple projects with good prioritization skills.
• Willingness to complete the work as per the committed timeline.

Technical Skills:

• Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects.
• Ability to identify inconsistencies and deficiencies in technical data and escalates for resolution.
• Thorough knowledge and experience of drug development practice, rules, regulations, and guidelines.
• Demonstrates knowledge of key processes, procedures and tools.

Regulatory Skills:

• Strong knowledge on the Regulatory requirements during both development and life-cycle management phases for US, Europe and other major markets and has expertise to oversee preparation and submission of complex regulatory submissions.
• Knowledge on current regulations and filings requirements for post approval.
• Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape.
• Adequate level of knowledge on general standards SOP, processes and policies of Pharma industry.

Leadership Skills:

• Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format.
• Ability to comprehend and summarize complex technical data.
• Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly with cross functional team to the negotiations.