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:





- 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