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
