Qualification : Graduate in Pharmacy
Functions as the Global Regulatory Owner (GPO) for assigned products, working with a cross-departmental team to prepare regulatory submissions and regulatory documents.
Ensures the deliverables assigned individually.
Prepares quality Global regulatory strategy document (GRSD), submission of dossiers/ supplements/ variations/ annual reports and other regulatory tasks as assigned.
Collaborate with global and other regional regulatory team to author quality regulatory submissions for the assigned products.
Provides adequate support to global and other regional regulatory team for securing approval of regulatory submissions including arranging samples and other administrative documents from Indian Health Authorities.
Complies with all standards, procedures and policies for submissions set forth for the Regulatory Function.
Remains knowledgeable about current regulations and guidance to perform day to day regulatory activities.
Good communication skills, both verbal and written.
Good conceptual, analytical, problem solving, and organizational skills.
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