What are the responsibilities and job description for the Regulatory Affairs-International position at Rareminds?
Job Description
Job / Position Title :
Function / Department :
Regulatory Affairs-International
Designation
Manager
Position Reports To :
V.P.-Regulatory Affairs-India
Positions Reporting Directly to This Position :
None
Primary Purpose of the Position :
New Position based in Latin America
MUST HAVE EXPERIENCE IN ANVISA
ANVISA- Brazil
INVIMA- Columbia
DIGEMID- Peru
COFEPRIS- Mexico
ISP- Chile
ANMAT- Argentina
Key words : Dossiers, submissions,
Requirements
ESSENTIAL DUTIES / RESPONSIBILITIES OF THE POSITION :
- Preparation and reviewing of CTD and ACTD dossier.
- Co-ordination with plant for Regulatory compliances.
- Timely achievement of monthly plan & timely query response.
- Get feedback from all the countries for respective variation, and their timely submission.
- renewals.
- Tracking and reviewing of document requirements of upcoming new filing in ROW and Emerging markets
Benefits
KNOWLEDGE / SKILLS / ABILITIES
eCTD, CTD, Validation, ICH requirements, should have filed biological, Biotech products in Brazil, Mexico, Argentina, Colombia in addition to Peru, Cuba and Chile. Worked for Submission / Pre-qualification with PAHO
EDUCATION
Graduate / Postgraduate in Pharma / Biotech Stream
DESIRABLE SKILLS
Fluent in English Speaking and writing
MINIMUM YEARS OF EXPERIENCE
8-10 years
KNOWLEDGE
eCTD, CTD, Validation, ICH requirements, ANVISA
SKILLS
CORE COMPETENCIES REQUIRED FOR THE POSITION : (BEHAVIORAL AS PER company COMPETENCY FRAMEWORK)
Planning :
Analytical thinking :
People Management :
Communication :
Team Leading :
Requirements
KNOWLEDGE eCTD, CTD, Validation, ICH requirements, ANVISA ANVISA- Brazil INVIMA- Columbia DIGEMID- Peru COFEPRIS- Mexico ISP- Chile ANMAT- Argentina