Akhil Shah

AKHIL N. SHAH
1018-550 Scarborough Golf Club Road Cell# 647-203-4411
Scarborough, ON M1G 1H6 akhil.shah@rogers.com

Regulatory Affairs Associate
• Pharmaceutical • Medical Device • Cosmetic • CRO

Proactive and results driven Pharmaceutical Regulatory Affairs Professional: with an exemplary record of delivering and implementing strategic initiatives to enhance precision in regulatory submissions. Diligent; conducting critical review of key documents for completeness and scientific accuracy. Articulate; recognized for establishing and maintaining profitable business relationships with external and internal customers. Action oriented; self motivated team player and leader. Consistent; meet and exceeds organizational specific goals and objectives with impeccable work ethic. Proven expertise in:
• Regulatory Submission (Pre-CTA, CTA, NDA) • Natural Health Product Submissions
• Health Canada Act & Regulations • Interpreting Health Canada guidelines
• Protocol Writing • Researching & Gathering Information
• Post-Marketing Compliance • Informed Consent Form

Post Graduate Diploma in Pharmaceutical Regulatory Affairs • Bachelor’s of Science • MS Office Suite • SAP • Lotus Notes • Corel • Label View

RELEVANT SKILLS
 Strong regulatory background including knowledge of the Food and Drug Act and Regulations with its governing policies and guidelines.
 Hands on experience with various regulatory compilations and submissions such as: CTA, NDA, NDS, modules as per CTD formats.
 Prepared NDS and NDA submission project, 100% compliant to Health Canada guidelines.
 Navigated regulatory agency websites to obtain guidance documents and administrative forms such as the 510k and PMA submissions for FDA.
 Arranged a mock Pre-CTA meeting package complaint to regulations and guidelines.
 Extensive exposure in dealing with internal and external customers.

PROFESSIONAL EXPERIENCE

Quality Assurance and Regulatory Affairs Associate 2008-2009
NowPac Inc.

Health Canada Approved facility providing co-packing needs for Pharmaceutical and Food Manufacturing Companies such as Johnson & Johnson, GSK, Novartis, Pfizer and Wrigley’s

 Developed project strategy to perform in-process quality checks to reduce the number of errors and improved efficiency resulting in a cost savings of 90%.
 Assisted in the development of processes and procedures to ensure compliance with the Food and Drug Act and Regulations and other applicable regulations and industry codes.
 Prepared reports on all deviations observed during the inspection to the department manager.
 Reviewed and assisted with quality manual, SOP review and training of new technicians.

Retail Banking Officer 2006-2008
Scotia Bank
Highly Regulated and Customer driven environment with stringent privacy policy

 Consistently delivered high quality customer service with score of over 75% in customer satisfaction and focused on first call resolution.
 Demonstrated can-do-attitude which resulted in over-achievement of 137% of sales target.
 Achieved 110% of targeted operational efficiency and ensured productivity goals.
 Organized team activities, positively impacted team morale and employee relations through positive interaction with team members.

Marketing/ Sales Support Assistant 2006
Cognis Canada Corporation
Cognis Canada is a provider of innovative specialty chemistry to local manufacturers and producers of personal & home care, nutrition and health, coatings & lubricants.

 Researched and organized a list of four hundred new potential customers for future business.
 Contacted potential clients for arranging meetings with Business Manager and Sales reps.
 Performed precise data entry, updated price in the SAP system and filing for sale department.

Medical Sales Representative/Business Manager 1992-2005
Ranbaxy Labs. Ltd
Ranbaxy India’s largest research based international pharmaceutical company. Ranked 8th amongst the global generic pharma companies with presence in 23of the top 25 pharma markets.

 Established 3 specialty divisions and 70 first in market products with consistent outperforming company –mandated sales quotas in a 14 year long career.
 Analyzed personality traits during the meeting with clients and obtain approval in the formulary of hospitals and developed key opinion leaders’.
 Researched potential opportunities within a limited market, prepared a business plan and established relationships with doctors and pharmacists to generate business resulting in the signing of 200 additional doctors with an average initial sales of 200,000.

EDUCATION AND TRAINING

Post Graduate Diploma- Pharmaceutical Regulatory Affairs, 2008
The Toronto Institute of Pharmaceutical Technology, Toronto, Canada

Bachelor of Science (Equivalent to Canadian Bachelor’s Degree evaluated by WES), 1989
M. S. University of Baroda, India

AFFILIATIONS
 CAPRA, Member 2008-2009
 HAPPEN, Active Member 2009