What you need.
University degree in Pharmacy, Chemistry, Biology, Biochemistry or in other area, but pertinent with the field
Preferably 3- 5 years of experience in pharmaceutical companies as Regulatory Affairs Associate or Regulatory Affairs Manager
Good communication skills (both written and verbal English) and interpersonal skills
Organized with good time management skills
Pro-active and result oriented
Must have an eye for detail and a methodical approach to work
Job description
Formulates or implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced;
Provides regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products;
Develops regulatory strategies and implementation plans for the preparation and submission of new products;
Monitors emerging trends regarding industry regulations to determine potential impacts on organizational processes.
Establishes regulatory priorities or budgets and allocate resources and workloads;
Manages activities such as audits, regulatory agency inspections, or product recalls.
Participates in the development or implementation of clinical trial protocols;
Provides responses to regulatory agencies regarding product information or issues;
