Project Management Manager

CHRISTOPHER FREDRIC M.Sc

Mississauga, ON 647-***-**** ac23rf@r.postjobfree.com www.linkedin.com/in/chris-fredric-ra-executive

PROFESSIONAL SUMMARY

A very experienced Regulatory Affairs executive in the biotech/pharmaceutical industry. Significant accomplishment in designing and implementing Regulatory strategies in achieving fast approval of drugs developed for rare diseases. Extensive experience in leading regulatory teams to prepare, file marketing authorizations and support the application through licensure & post approval process with FDA, EMA, Health Canada, Middle-East, North Africa, Israel, Asia, Latin America and other international regulatory agencies.

- A strategic thinker, proactive with a global perspective and goal oriented

- Proven track record of success. Brings a wealth of knowledge in pharmaceutical product development

- Excellent project management and organizational skills

- Experience in pharmacovigilance activities for marketed products, product launch submissions including Advertisement, Promotional Labeling, and patent searches

- Identifies, selects and engages high-performing teams

- In-depth understanding of biotech business

- Vast knowledge of ICH Guidelines, GMP, GCP and GLP including international regulatory requirements for clinical development programs

EMPLOYMENT HISTORY

Alexion Pharma Canada

Associate Director, Regulatory Affairs Jun 2013 – Oct 2017

As Head of Canadian Regulatory Affairs and member of Senior Leadership Team, strategically built and maintained contacts with Health Canada, developed and executed regulatory strategies and tactics, prepared, filed, supported the application through licensure, received conditional approval for an Enzyme Replacement Therapy, and managed post approval process with BGTD. Authorized signing official, responsible for all Health Canada submissions including marketing authorizations, product life cycle maintenance, clinical trial applications, maintenance of GMP clearance and Art work compliance.

• Built an RA team, supervised, mentored and managed workload of team members

• Designed, led, implemented regulatory strategies for new products and provided expert advice to Global Regulatory Leads

• Provided country specific regulatory intelligence, strategized and executed plans to overcome regulatory hurdles to both Commercial Operations and Global Regulatory Affairs

• Designed, led and implemented strategies for several Marketing applications to Health Canada in line with Health Canada guidelines, Alexion SOPs, Corporate objectives and received approval in a single review cycle

• Authorized Drug Safety Officer, responsible to report adverse events for marketed and developmental products

• Authorized Quality officer, responsible for Health Canada inspections, DEL renewal. Managing regional change- controls and perform SME reviews for global change control

Optum Insight

Associate Director, Regulatory Affairs Jan 2013 – May 2013

Responsible for Pre-and post-regulatory submissions for biologics and pharmaceuticals with FDA. Collaborated closely with client’s subject matter experts.

Covalon Technologies Inc.

Manager, Clinical & Regulatory Affairs Apr 2012 – Jan 2013

Responsible for Pre-and post-regulatory activities for Class II, III and IV Medical Devices, ensured fully compliant with FDA, EMA, Health Canada, TGA & other international regulatory requirements.

• Collaborated closely with personnel in other functional units, contract manufacturing or research organizations. Supported regulatory activities related to price and reimbursement

Cangene Corporation

Manager, Regulatory Affairs 2008 - 2012

Led regulatory teams, developed and executed regulatory strategies and tactics, prepared, filed, supported the application through licensure, received marketing authorizations, and managed post approval process with various regulatory agencies such as FDA, BGTD, EMA, Israel, GCC, Latin America, MENA region, Turkey & Asian countries. Identified, assessed impact of global regulatory changes on Cangene products and communicated to teams.

• Built an RA team, supervised, mentored and managed workload of team members

• Strategized, submitted and received approval of a BLA from FDA in 1st cycle review

• Fast Track submission, Priority Review approval, Orphan Drug Designation & marketing exclusivity

• Appealed to BGTD to reverse their decision on issuing a NOD and received approval (NOC/c policy)

• Strategized, submitted marketing authorization application through the Centralized Procedure to the EMA and received centralized approval in a single review cycle

• Labeling, advertising and promotional materials. Global pharmacovigilance activities

Supervisor, Regulatory Affairs 2007 - 2008

Senior Regulatory Affairs Associate 2004 - 2007

Cobalt Pharmaceuticals Inc.

Senior Regulatory Associate 2002 – 2004

Sanofi Pasteur

Regulatory Associate 2001 – 2002

Research Technologist 1995 – 2001

Vaccine development for Chlamydia pneumoniae and Respiratory Syncytial Virus (RSV).

Advanced Biological Products

Research Scientist 1994 - 1995

EDUCATION

M.Sc. Clinical Biochemistry 1994

University of Toronto

PhD-All but dissertation 1987-1992

Anna University

Graduate Research Biochemistry Completed all academic requirements for PhD.

M.Sc. Zoology University of Madras 1987

B.Sc. Zoology University of Madras 1985

PROFESSIONAL DEVELOPMENT

• Global Perspectives of Successful Drug Development-DIA Germany

• European Regulatory Affairs-Portugal Organized by RAPS

• Canada & the Common Technical Document Organized by CAPRA

• Stability Program-ICH Perspective and Process Validation Organized by Aventis Pasteur

• The Active Leadership Program and Project Management Gilmore & Associates

• Part-time Professor International/Canadian Regulatory Affairs, Seneca College (RAQC Program) since 2008

Contact this candidate