Salary :
Activity area :
Pharmaceutical and medical
Post category :
Scientific and technical positions
Our client a world leader in life science and is presently looking for an Associate Director - Regulatory Affairs.
You will oversee assigned projects and coordinates Regulatory Affairs Associates.
Responsibilities include preparing, compiling, writing, and reviewing international registration dossiers, and managing the filing, tracking, and approval of regulatory documents.
The role involves managing the regulatory affairs department, aligning regulatory strategies with corporate objectives, and overseeing worldwide CMC regulatory activities.
It includes developing strategies for pre-approval projects, conducting gap analyses, and ensuring compliance.
The incumbent handles post-approval changes, maintains communication with regulatory customers and agencies, responds to information requests, and ensures compliance with international regulations.
They manage periodic safety updates, supervise staff, collaborate on cross-functional teams, allocate resources, and prepare budgets.
Skills and qualifications :
We are looking for a candidate from the industry with 8-10 years of experience
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