Associate Director of Regulatory Affairs

• Feb 2022 - Present

Regulatory Affairs Manager

• Mar 2018 - Feb 2022

Responsible for managing the CMC team at PAI, providing guidance and direction for regulatory filings with the US FDA for the largest Unit Dose liquid drug product manufacturer in the US. Support the Regulatory Affairs department in assessing proposed process changes for regulatory impact. Provide guidance to various project teams to support drug development and commercial manufacturing for more than 50 commercial prescription and over-the-counter products. Support labeling, drug safety, compliance and staff development activities as needed.

Regulatory Affairs Manager

• Sep 2017 - Mar 2018

Responsible for supporting clients US and EU regulatory submission strategies. Participate in multidisciplinary project teams with the client providing guidance and direction on current regulatory pathways and expectations. Write and review regulatory submission documents with a critical eye for suitability to FDA and any other regulatory agencies requirements. Remain current on changes to the regulatory environment that could impact the company's contract manufacturing strategies. Monitor applications under review, manage and track submission and maintenance processes to support regulatory applications. Work with quality and document control groups to ensure proper assessment of documents and regulatory document archiving.

Regulatory Affairs Manager

• Mar 2011 - Sep 2017

Competently managed a CMC submission under the pressure of a shortened submission time-line and was subsequently promoted to RA manager. Written numerous CMC submissions in eCTD format filed with FDA, EMA and Health Canada. Develop and encourage cross-functional relationships, both internally and externally, to foster understanding of global regulatory strategy and provide innovative solutions to enhance the probability of regulatory success and compliance. Successfully managed FDA cGMP compliance and pre-approval inspections. Navigate and support client submissions to FDA, EMA, Health Canada, UK-MHRA, TGA (Australia) and Japanese Ministry of Health. Develop training documents and standard operating procedures to support the regulatory and quality assurance process. Evaluate proposed changes to commercial manufacturing operations for regulatory impact and filing requirements. Mentor, educate and train other regulatory and quality staff to enhance regulatory knowledge. Provide guidance and review support for analytical and process validation projects. Author and review technical reports including: annual product reviews, analytical and process validation documents, equipment qualifications, deviations and change controls.

Teacher

• Aug 2000 - May 2009

Wrote the district-wide science curriculum and coached a winning Science Olympiad team. Developed the leadership and management skills necessary to effectively lead others. Created and implemented daily learning opportunities for a diverse student population. Effectively lead a number of staff development opportunities for colleagues. Wrote the district-wide science curriculum and coached a winning Science Olympiad team. Developed the leadership and management skills necessary to effectively lead others. Created and implemented daily learning opportunities for a diverse student population. Effectively lead a number of staff development opportunities for colleagues.

Chemist

• Jun 1998 - Jul 2000

Successfully worked part-time while in graduate school and finished at the top of my class. Developed a proficiency in various analytical techniques including: HPLC, GC, IR, extractions, distillations and wet-chemistry techniques. Maintained detailed records. Successfully worked part-time while in graduate school and finished at the top of my class. Developed a proficiency in various analytical techniques including: HPLC, GC, IR, extractions, distillations and wet-chemistry techniques. Maintained detailed records.

Chemist

• Jun 1993 - Jun 1998

Established myself as an analytical chemist and was promoted to trace-metals department. Learned various techniques including: AA, extractions, distillations and wet-chemistry techniques. Established myself as an analytical chemist and was promoted to trace-metals department. Learned various techniques including: AA, extractions, distillations and wet-chemistry techniques.