senior specialist_license management in chennai

posted
contact
randstad india
position type
temporary
apply now

posted
location
chennai, tamil nadu
function
Pharma, healthcare & lifesciences
position type
temporary
experience
3
reference number
55722
contact
randstad india

job description

senior specialist_license management in chennai

**Job Specific Competencies & Skills:** * Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations * Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset) * Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally * Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO's, AFs, CLs, PoA's etc.) as well as legalization framework * Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request * Adherence to agreed timelines and proactive communication of any potential risk to the same * Project management and documentation skills, proactive communication approach * Contributor level of experience with RIM and EDMS RA applications * Excellent written and spoken English language

skills

Regulatory affairs

qualification

PG Diploma