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Senior Leader in Regulatory Affairs and Quality

Location:
Coral Springs, Florida, 33076, United States
Posted:
March 24, 2019

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Resume:

Preeya

Hanke

754-***-****

ac8vy4@r.postjobfree.com

***** ** ** *****

Coral Springs, Florida,

33076

SUMMARY

Senior Regulatory Affairs/Quality Leader with more than 25 years of experience in Health Care

Strong understanding of departments within R&D, Clinical, Quality and Manufacturing, marketing and supply chain

Proven record in developing RA strategies and timely global filing and approvals of CTA/IND, NDS/NDA, S/NDS/ANDA and other types of submissions including Medical Devices

Extensive understanding of Canadian, US and International healthcare legislation, regulations, guidelines and practices

Responsible for global alignment Subject Mater Experts Direct interface with Global teams, local Health Authorities and international stakeholders Experience with branded and generic pharmaceuticals, medical devices and biologics SKILLS

• Results oriented combined with strong

business acumen

• Proven track of leadership and team

building

• Effective Communicator

• Global systems/process harmonization

• Global submission and publishing

• Effective Regulatory Inspection

readiness/management

• Proficient with Microsoft Office

EXPERIENCE

Director Regulatory Affairs

Mississauga, ON

GenReg Biomedical Solutions Inc./ Apr 2018 to Current

Set up Regulatory Affairs Department to service International Markets

Provided Regulatory and Quality support for clients in USA, Canada and China

Head Regulatory Affairs

Mississauga, ON

Baxter Corporation/ Apr 2015 to Mar 2018

Responsible for providing leadership and coaching along with regulatory and pharmaceutical science knowledge to the company's portfolio of products and medical devices

Successfully led and provided regulatory expertise related to product development; regulatory strategies, regulatory submissions including CTA/IND, NDS/NDA, S/NDS/ANDA, Medical Device Licences and influenced Health Authorities for early products approvals

Managed department budget of 4M$

Member of the Senior Management team

Manager, Regulatory Affairs

Mississauga, ON

Baxter Corporation/ Mar 2004 to Mar 2015

Responsible for development of New Products strategies with global teams for Baxter's portfolio to ensure successful outcomes

Led the Pharmaceuticals portfolio including Oncology, Nutrition, IV drugs and solutions, Renal products and Medical Devices for submissions, approvals and product life cycle maintenance

Managed Third party products marketed and distributed in Canada and other international markets

Managed a team of 7 professionals

Sr. Regulatory Affairs Specialist

Mississauga, ON

Baxter Corporation/ Jan 2002 to Mar 2004

Managed and maintained Pharmaceuticals, Biologics and Medical devices portfolio

Senior Manager Regulatory Affairs and Quality

Mississauga, ON

Crystaal/ Mar 1998 to Jul 2000

Conducted due diligence for in-licensing of global partner products Set up Regulatory and Quality Systems for department Managed life cycle products, including CTAs, NDS submissions, promotional materials, product release and GMP compliance at distributors

Head of Quality

Mississauga, ON

Genpharm Inc./ Mar 1994 to Nov 1996

Responsible for Quality Control and Quality Assurance operations to ensure cGMP compliance for products marketed in Canada and international markets Responsible for Global Health Authority Inspections as well as local Government and Customer Inspections

Led a team of 42 professionals

Senior Manager Quality

Toronto, Canada

Glaxo/ Mar 1990 to Feb 1994

Responsible for the development, direction, execution and compliance of the Company's Corporate Quality program

Responsible for chemistry and microbiology lab operations Ensure cGMP compliance for manufacturing, API and packaging suppliers; Provided coaching and guidance for release of products for sale and complaints handling. Set up Regulatory Affairs Department to service International Markets

EDUCATION AND TRAINING

Bachelor of Technology, Chemical Engineering

Ryerson University

Toronto, Canada



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