Regulatory Affairs Quality Control

MONICA SMITH

**** ********* *****, *******, ***** Carolina 27610

**************@*****.***

OBJECTIVE

To align myself with a company which is controlled and operated by people of integrity, whose services are of unquestionable quality, and which is prepared and planning for continued growth.

SKILLS

Risk-Management, Compliance – Strategic Planning, Pharmaceutical Industry, Testing, Training, Project Management, Administrative Support, Dexterous in Microsoft Office Products, Skilled in U.S. Food and Drug Administration (FDA), Excellent Communication Skills, Quick adaptability

A highly resourceful, innovative, self-motivated and energetic professional with years of experience in a corporate environment. A persistent force that overcomes challenges to achieve monumental results. Flourishes in high-pressure situations, instilling a calm climate that increases productivity.

EXPERIENCE

REGULATORY AFFAIRS SPECIALIST*OTSUKA PHARMACEUTICALS*AUGUST 2021-DECEMBER 2024

Prepared standard documentation supporting regulatory filings and submissions to the U.S. Food and Drug Administration (US FDA) within electronic databases (Veeva and CREDO).

Ensured all materials were places in the repositories by using the structured format.

Provided Quality Control of all submitted documents ensuring accuracy and completeness of the submissions.

Served as primary liaison for assigned brands: Rexulti, Abilify MyCite, Abilify Maintena, Jynarque and Nuedexta.

Effectively communicates and interacts with colleagues and collaborators.

Aligned with the brand teams to ensure submission packages were reviewed and finalized for proper submission through the electronic gateway.

Kept track and updated the 2253 Handbook and Document Management Compendium.

Provided Veeva Training on 2253 process.

Assisted with New Hire Training

Other duties as assigned

REGULATORY COMPLIANCE ASSOCIATE*GLAXOSMITHKLINE*January 2008-2019

Managed the operations involved in the review and approval of promotional material to ensure efficient and effective development, approval, production and distribution of 3,600+ promotional materials across all Respiratory Business Units.

Drove the copy and approval process objectives along with internal and external stakeholders by managing the content review process and approval material.

Served as primary liaison for assigned brands: ViiV, Nucala and Benlysta, with Marketing, Regulatory Affairs and agencies/vendors regarding adherence to GSK policies and compliance with FDA and Legal requirements.

Performed fine quality control on all FDA 2253 filings for completeness and compliance per GSK and FDA (OPDP, APLB) requirements.

Partnered with the Project Managers and Brand Mangers to ensure the critical timelines were met.

Developed the content for the 2253 Overview Module on the CA Portal.

Worked with the Promotion Compliance Manager and the Regulatory Affairs team on the simplification of standard language for the comment section on the 2253 Form.

Partnered with System Analyst to establish a consistent and efficient process for adding new brands, NDA/BLA’s and prescribing information codes for product launches and label updates.

Lead Promotion Compliance Associate (PCA) system testing of the Copy Approval electronic routing system (ie. Planner) as related to final sample process and 2253 workflows.

Collaborated with Regulatory to implement and standardize the 30-Day hold and 2253 submission process.

EDUCATION

HIGH SCHOOL DIPLOMA*HERITAGE HIGH SCHOOL

Advanced Honors

REFERENCES

References will be provided upon request

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