Regulatory Affairs Specialist Resume Example Baxter Healthcare Corporation

REGULATORY AFFAIRS SPECIALIST

Skill Highlights

Strong project management, organization and collaboration skills
Proficient with quality computer systems, enterprise systems, Adobe and Microsoft Office including Word, Excel, Power Point, and Outlook
Adaptive team player

Strong customer focus; maintain relationships while continuously meeting project timelines
Excellent written and verbal communication
Detail oriented

Professional Experience

Regulatory Affairs Specialist
March 2015 to January 2016Baxter Healthcare Corporation － Bloomington, IN

Responsible for providing regulatory support across three (3) separate Baxter facilities, including participating on cross-functional teams
Authored regulatory project plans and provided support to Pharma Partners seeking major market approval of their drug application (US, Europe, Canada)

Maintained regulatory submission files in accordance with ICH and regulatory requirements.

Responded to agency deficiency requests within strict timelines
metrics
provided ongoing support to junior level associates to help develop their knowledge of regulations and procedures

Regulatory Affairs Senior Associate
February 2012 to March 2015Baxter Healthcare Corporation － Bloomington, IN

Participated on a cross-functional team to support implementation of a Master Diluent Program. Provided regulatory risk evaluation and guidance to ensure compliance with governing regulations and to mitigate deficiencies within the design space.
Coordinated and wrote global regulatory applications; responsible for lifecycle maintenance of eight (8) Drug Master Files (DMFs), Site Master File and Validation Master Plan.
Maintained regulatory submission files in accordance with ICH and regulatory requirements.
Lead the effort to convert BPS DMFs into electronic Common Technical Document (eCTD) format; successfully converted four (4) out of eight (8) DMFs and submitted to FDA in eCTD format within established timelines.
Responded to agency deficiency requests within strict timelines.
Authored project plans and provided support to Pharma Partners referencing BPS DMFs in accordance with established timelines.
Perform change control assessment and provide notification of proposed facility changes for regulatory impact to approved Pharma Partner marketing applications.
Provided guidance and coaching to team members for international filing support.

Quality Associate II - Stability Program Lead
August 2008 to February 2012Baxter Healthcare Corporation － Bloomington, IN

Successfully managed the execution and maintenance of stability programs for 15 Pharma Partners and 3 Proprietary products; maintained 99.4% on-time delivery and generated ~$2.5M annually.
Wrote and maintained stability protocols and project plans used to support regulatory submissions for Pharma Partners and Proprietary products.
Collaborated with Regulatory Affairs personnel to ensure accuracy and completeness of Proprietary stability study data reflected in regulatory documents.
Assisted in internal, client and regulatory audits; compiled audit observation responses and completed audit response action items in an accurate and timely manner.

Quality Associate I - Microbiology Analyst
September 2006 to August 2008Baxter Healthcare Corporation － Bloomington, IN

Authored exception and investigation reports for deviations with the potential to impact the integrity of finished product.
Coordinated and performed bioburden method validations, bacteriostasis/fungistasis sterility test method validations, sterility testing of finished product and stability samples, in-process bioburden testing, microorganism identifications, and environmental monitoring of classified areas.
Trained new access users for laboratory support software systems.

Education and Training

Bachelor of Arts : Biology, 2006Indiana University － Bloomington, IN, USA

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