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 workplace.
Attention to detail and accuracy required.
Must be able to prioritize with independently/minimal guidance.
Ability to handle multiple projects with positive 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:




Solid 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.

📌 Regulatory Manager Mumbai
🏢 Olon Active Pharmaceutical Ingredients India Priva Te
📍 Mumbai