Sr. Associate,regulatory Affairs
hace 2 semanas
Reporting to the Registration & Regulatory Compliance Manager, the Sr. Associate will support registration and compliance of SCJ products within Southern Cluster. You will focus on meeting internal and external legal requirements of a broad portfolio, being interface with different stakeholders, to assure commercialization of compliant goods. This includes, but not limited to: submission of new registration, amendments and renewals; label development; complete internal systems to maintain registration information updated; support local and global initiatives to improve processes; participate in trade associations.
**Essential Duties and Responsibilities**:
- Manage internal and external requirements to submit registrations, amendments and renewals.
- AW development and approval, providing the specific regulatory information required per country.
- Follow up with consultants and agencies to obtain registration approval.
- Provide input at an early stage of the process about registration strategy.
- Detailed registration requirements per country.
- Attend local audits as audited/auditor if needed
- Support and attend Global internal audits, assuring and proving registration and compliance health in the region. Coordinate and held meetings with local/regional consultants, in order to receive technical support for different projects, and provide directives about next steps.
- Attend to meetings in trade associations and regional forums (as MERCOSUR), to receive the latest news and trends in the region and participate actively to safeguard best interest of the company.
- Provide feedback in advance for advertising development, from a regulatory standpoint.
- Review and approve advertisement pieces, from local and/or global teams
- Request guidance from consultants and/or government if needed.
**Required Skills / Experience / Competencies**:
Required skills are those that are absolutely necessary to perform the job and can be objectively measured, such as high school diploma, driver’s license, Bachelor’s degree in “x” field, etc.
- Bachelor’s degree student (final phase of the career) /recently graduated as Pharmacist (mandatory)
- 1+ year of work experience in any field, technical areas desirable.
- Intermediate/Advanced English level (mandatory)
- Ability to accurately collect information and ask probing questions to understand and assess the colleagues needs.
- Strong customer service.
- Analytical skills.
- Ability to prioritize workload and provide timely follow-up and resolution.
- Skilled in conducting research and using existing knowledge to resolve inquiries.
- Possesses problem solving skills.
- Skilled in developing professional relationships with colleagues, supervisors, and peers
- Microsoft Work/excel experience (mandatory), SAP is a plus.
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