Post Graduate in Pharmacy or Science.
Target years of experience: 7 to 10 years of experience in Regulatory Affairs in a reputed Pharmaceutical Organization
Type of experience: Leading a team in the Regulatory Affairs function in a reputed Pharmaceutical Organization
Functions as the regulatory lead working with Global product owners and a cross-departmental team to ensure preparation of quality global regulatory strategy document and dossier / supplements/ annual report as assigned to the team.
Ensures key deliverables assigned to the team
Provides review support and guidance to Global product owners on technical and regulatory knowledge towards preparation of Global regulatory strategy document (GRSD) , dossiers/ supplements/ variations/ annual report and other regulatory documents as assigned to the team
Provide regulatory support to the cross functional teams for the assigned product
Collaborates with and ensures adequate support to the regional team to ensure completion of assigned task or goal.
Identify and assess regulatory risks associated with assigned projects and timely communication to the leadership team to quickly mitigate the risks
Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects
Actively trains/mentors team members for the effective execution of assigned tasks and goals
Good communication skills, both verbal and written, and the ability to interface effectively with cross functional team and regional regulatory teams
Good conceptual, analytical, problem solving, and organizational skills
Good team management skills
Candidates are preferred from Baroda in around Location