Regulatory Affairs Manager Job

Regulatory Affairs Manager is needed to perform the following duties :

• Manage preparation for submissions: Original ANDA’s, Prior Approval Supplements, CBE-30s, CBE-0s, Annual Reports, etc.
• Responsible for assembly of ANDA submissions working directly with CMO’s and development partners.
• Track Regulatory activities via project management tools such as excel, MS project, etc
• Organize and update Regulatory files in Novo space and internal drives
• Experience with Adobe Illustrator® or equivalent is preferred.
• Responsible for labeling generation including inserts, container and carton labels, patient brochures, etc., and Labeling submissions to FDA.
• Responsible for preparation of post marketing reporting such as 15-Day MedWatch’s, Periodic Safety Reports, compiling relevant information provided by partners and CMO’
• Responsible for compiling information required for drug listing.
• Communicate and provide information to partners upon request
• Provide presentation material for management updates.
• Partner owned ANDAs: * Communicate and provide information to partners upon reques
• Partner owned ANDAs: * Work closely with partners and CMO’s for labeling development and review.

Bachelor’s Degree is required in Regulatory Affairs or Drug Regulatory affairs or education + experience which is equivalent to a Bachelor’s Degree in Regulatory Affairs or Drug Regulatory affairs