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Fayez Alshehri, Regulatory affairs manager of Johnson & Johnson

Fayez Alshehri

Regulatory affairs manager of Johnson & Johnson·Johnson & Johnson

Saudi Arabia

Bachelor's degree, Pharmacy

Work experience

Total years of experience: 16 years, 4 months

Regulatory affairs manager of Johnson & Johnson

March 2011 - May 2012

Johnson & Johnson

Canada

March 2011 - May 2012

March.2011 - Now: Regulatory affairs manager of Johnson & Johnson
Consumer.
o Build a strong & reputed relations with all relevant parties
o Ensure that company complies with all local regulations & guidelines.
o Crisis management.
o Licensing of a new products & plants.
o Manage & control of Counterfeit & Parallel import.

2
o Organize training courses for the authorities' staffs.
o Open new channels for a business by solving regulatory problems.
o Renew of expired products & plants.
o Double check the conformity certificates.
o Licensing consumer products & make them complying with local guidelines.
o Check artworks & promotional tools to comply with local rules.
o Put a company in a picture of regulations & new decrees.
o Listing of non pharmaceuticals on relevant authorities' database.
o Participating on a management meeting to approve the new projects & strategies.

Character Reference
• Dr. Riyadh Alashban
Central laboratory for drugs and food analysis - SFDA
Tel: +9661 4355555
Extn: 1644
• Dr. Nasser Alhowaimel.
Pricing Unit Manager. - SFDA
Tel: +9661 2038222
Extn: 5310

Company industry:
Pharmaceutical Manufacturing
Job role:
Other

Scientific office manager of Mepha Swiss

November 2003 - February 2011

November 2003 - February 2011

Nov.2003- Feb.2011: Scientific office manager of Mepha Swiss.

o Build a reliable & strong relations with all relevant authorities & partners.
o Participating in the board meeting to approve the new projects & approaches to perform.
o Represent a company in front of relevant authorities.
o Ensure that company complies with Saudi & GCC regulations.
o Registration of new products & plants.
o Renew of old registered products & plants.
o Pre-Audit of the new plants before submitting them to the authorities.
o Clear & solve an urgent & official use shipments.
o Evaluate & analyze the new projects.
o Increase company sales & profit by licensing new products.
o Crisis management.
o Recall & Media problems.
o Artworks & Packaging revision & approve.
o Promotional materials review & approve.
o Get an official approval for Seminars, Symposium & Advertising campaign.

Job role:
Other

affairs assistant manger

September 2001 - February 2003

Medical & Regulatory

September 2001 - February 2003

Sep. 2001 -Feb. 2003: Medical & Regulatory affairs assistant manger
Abbott Laboratories S.A.
Riyadh, Saudi Arabia
(As of Sep.2001, Knoll AG was wholly acquired by Abbott Laboratories)
o Prepare and submit applications for registration of new products and variations to the current marketed products.
o Review labeling, product information, consumer product information for compliance with relevant regulations and codes..
o Follow-up with MOH officials on regulatory issues.

Job role:
Other

Scientific Office Manager

September 1999 - August 2001

Knoll AG- German

September 1999 - August 2001

Sep. 1999 - Aug. 2001: Scientific Office Manager
Knoll AG- German.
Riyadh, Saudi Arabia
o Handling all registration issues.
o Re-registration (Re-sourcing) of all ex-Boots products (Brufen 400
mg, Brufen 600 mg, , Froben, Prothiaden)
o Registration of new manufacturing sites in France (Laboratories
Knoll France- LKF) and in Spain (Laboratories Knoll Spain- LKE)
o Registration (Reductil® 10, Reductil® 15)

Job role:
Management

Scientific Office Manager

July 1997 - July 1999

Egyptian International Pharmaceutical Industries

July 1997 - July 1999

July 1997 - July 1999: Scientific Office Manager
Egyptian International Pharmaceutical Industries
Company - EIPICO
Riyadh - Saudi Arabia
o Managing all government issues. e.g.: Registration, Re-registration,
Resourcing, Changes management, Sites registration, Clearance,
Import permissions, Tenders, Direct purchase etc.
o Representing of the company in front of the major institutions
(MODA, National Guard, SFH, KFSH&RC etc)


1

Company industry:
Pharmaceutical Manufacturing
Job role:
Management

Warehouse Manager

May 1995 - June 1997

Saudi Import Company SIC_BANAJA

May 1995 - June 1997

May 1995 - June 1997: Warehouse Manager
Saudi Import Company SIC_BANAJA
Riyadh - Saudi Arabia

Job role:
Logistics and Transportation

Education

King Saud University

January 1995

January 1995

Bachelor's degree, Pharmacy

1989 - 1995: Bachelor of Science in Pharmacy King Saud University Riyadh - Saudi Arabia

Skills

Regulatory Affairs
Expert
Regulatory Affairs
Expert
Governmental Affairs
Expert
Governmental Affairs
Expert
Regulatory Filings
Expert
Regulatory Filings
Expert
Market Access
Expert
Market Access
Expert
GMP
Expert
GMP
Expert
AUDIT
Expert
AUDIT
Expert
CONSUMER PRODUCT
Expert
CONSUMER PRODUCT
Expert
CRISIS MANAGEMENT
Expert
CRISIS MANAGEMENT
Expert
INCREASE
INCREASE
NEW PRODUCTS
Expert
NEW PRODUCTS
Expert
OFFICE MANAGER
Expert
OFFICE MANAGER
Expert
Regulatory Affairs
Expert
Regulatory Affairs
Expert
Governmental Affairs
Expert
Governmental Affairs
Expert
Regulatory Filings
Expert
Regulatory Filings
Expert
Market Access
Expert
Market Access
Expert
GMP
Expert
GMP
Expert

Languages

Arabic

Expert

English

Expert