Regulatory Affairs Associate/Pharmaceutical

Assist in ANDA pre-and post-approval activities including but not limited to initial applications, annual reports, safety reports, supplements and amendments.

 

Responsibilities:

 

· Prepare and submit labeling information to regulatory authorities.

· Prepare minor post approval supplements / annual reports to support changes and/or to manage the regulatory product life cycle as applicable under supervision.

· Assist in product launch activities.

· Develop and maintain working knowledge of US FDA regulations.

· Other duties as assigned.

 

Education/Experience:

 

· Qualified candidates will have a Bachelor’s degree in Chemistry, Pharmacy or Life Sciences with minimum 1 - 3 years pharmaceutical/device/diagnostic or biologic industry experience.

 

· Excellent writing and oral communication skills. Strong attention to detail and ability to multi-task. Must work well in team environments.

 

· Excellent personal computer skills, specifically Microsoft Office, Adobe Acrobat. Experience with SAP and electronic publishing an asset.

 

Planning and Organizing Tasks

Must be able to prioritize and organize assignments.

 

Physical and Environmental Conditions

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing.  In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply.  In general the activity level one usually performs is light physical activity performing non-strenuous daily activities of an administrative and sedentary nature.  This position may require lifting up to 25 pounds.  Generally work is performed in a well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation. 

 

Work Schedule

The regularly scheduled work week is Monday - Friday and the hours are 8:30a – 5:30p.

 

Travel Requirements

Occasional overnight travel (up to 10%).

 

Apotex Corp. offers 100% company sponsored Medical, Dental, Group Term Life, Voluntary Life, Disability, 401(k) Matching Contributions, Holiday and Vacation Benefits.  Apotex Corp. is an Equal Opportunity Employer.

 

Only resumes submitted in Word format will be considered.

No phone calls or recruiters please.

Local candidates only.