Regulatory Affairs Specialist

2 meses atrás

São Paulo, Brasil Fortrea Tempo inteiro

Job Overview:

Responsible for creation/revision and compilation of stability data and annual product quality review documents for submission by Fortrea clients to LATAM and oversight of the same. Should be proficient in English, Portuguese, Spanish languages. Knowledge of LATAM quality regulations.

Summary of Responsibilities:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally.

Prepare, compile & review Regulatory/Quality documents to support submissions to various LATAM markets. Extract (or receive) stability data from client or External manufacturing site at the final stability point Review data from Stability Points Prepare Stability Report (following Clients template) and send for internal approval Perform statistical evaluation and trend analysis following client’s procedure (when applicable) Prepare stability and annual product review (APQR/APR-PQR) report to share with client for review Initiate approval in client´s system Participate in discussions when requested by client. Be accountable to assure quality & compliance with procedures and customer requirements. Identify potential issues, perform trouble shooting, resolve conflicts and provide solutions for technical documentation related activities, coordinate the issues timely Seek guidance from other team members and manager as needed, and enhance Regulatory knowledge Perform additional duties as assigned by the manager  Implement use of consistent, efficient, and quality processes to meet timelines and deliverables according to Client requirements. Ensure compliance of operations with governing regulatory requirements. Maintain a culture of high customer service. Assume ownership of an assigned task or deliverable.

Qualifications (Minimum Required):

Bachelors/ Masters in pharmacy, analytical chemistry, biochemistry, or equivalent. Proficient in English, Portuguese, Spanish languages reading & writing skills Interpersonal skills, Proactive, Taking ownership, Precise, Goal oriented.

Experience (Minimum Required):

Previous years of experience with analytics or stability (Formulations and bulk drugs) in a GMP environment with proven Scientific / Technical skills Technical proficiency with Microsoft Office suite of applications/ Document Management and publishing tools. Good understanding of the pharmaceutical product life cycle. Good organizational and time management ability. Excellent interpersonal skills. Good analytical capabilities and Customer focus. Good review skills and concern for quality. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH-GCP guidelines desirable.

Preferred Qualifications Include:

Knowledge of statistical evaluation will be preferred Diploma or certification in Regulatory Affairs will be preferred Interpersonal skills, Proactive, Taking ownership, Precise, Goal oriented.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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