for individual studies and ISS/ISE to FDA, EMA, and other worldwide regulatory agencies Participate in the review of statistical...
and organizational skills. Ability to work under pressure and manage changing priorities. Familiarity with FDA and EMA guidance...
knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents. Familiarity with CDC compliance requirements... testing, test method transfer). b. Required Skill 2: Strong working knowledge of cGMP, FDA and EMA GMP regulation...
audiences. Familiarity with clinical trial design, execution, and regulatory requirements (e.g., FDA, EMA). Excellent...
of clinical trial processes, ICH/GCP guidelines, and FDA/EMA regulations. Strong analytical, organizational, and problem-solving...
) · Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) · A broad knowledge of life-cycle...
with GMP management and exposure to regulatory authorities like FDA, EMA, PMDA, or ANVISA. Preferred experience...
. Ensure compliance with industry regulations (cGMP, FDA, EMA) and company standards. Collaborate with cross-functional teams...
. Experience of first hand GMP management is essential, and will include exposure to FDA / EMA / PMDA / ANVISA or other authorities...
is essential, and will include exposure to FDA / EMA / PMDA / ANVISA or other authorities of similar standing. Why Choose R...