Friday, April 23, 2010

Regulatory Affairs Associate required

We need 
REGULATORY AFFAIRS ASSOCIATE in a Pharmaceutical industry
Salary is NOT A CONSTRAINT for a right candidate
Location-COLUMBIA

Specific Outcomes / Accountability:

The following will be the main areas of responsibility: 

  • Knowledge of ICH, US, EU and GMP guidelines;
  • Proven experience in Regulatory submissions in all major and minor Latin American Markets and able to provide expert advice on appropriate regulatory strategies for product registrations
  • Proven experience in   handling of different  variations in all Latin- American countries
  • Able to coordinate with all  in-country regulatory agents and monitor the regulatory submissions on regular basis and resolve any issues related submissions
  • Knowledge of  Pharmacovigilance  requirements in all these markets
  • Able to all  handle the customer queries in the region .
  • Ensuring Good Regulatory Practices are followed for all regulatory submissions in the market
  • Able to Liaise with Regulatory agencies, partners, customers, and the agents in the region
  • Proactively troubleshoot technical/quality issues relating to the preparation and submissions;
  • Review and approval of annual product reviews for submitting to Regulatory authorities.
  • Liaise with counterpart and applicable line functions for problem solving ,ensuring agreed upon action is implemented;
  • Maintenance of the record of post registration technical variation and labeling changes and advising the labeling team accordingly ;

Qualifications & Experience:

  • Pharmaceutical Specialist
  • 4 – 8 years proven experience in a regulatory environment with specific reference to International Pharmaceutical Operations
  • Thorough understanding of the global regulatory environment particularly relating to numerous license changes and new registrations
Key Attributes & Competencies:
  • Strong commercial acumen
  • Excellent interpersonal and communications skills
  • Good IT skills
  • Ability to work under pressure and meet tight deadlines
  • Ability to work in a fast moving International environment
  • Excellent in English
Sent your Biodata to ......riya@mpdgroupmail.com,biodata@mpdgroupmail.com
feel free to contact to;- 0091484-2838115,3295930,9287608882