Regulatory Affairs Manager

The Regulatory Affairs Manager will focus on the coordination and documentation of the internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. In addition, the RA Manager will compile and prepare materials for submission to regulatory agencies

Position Title: Regulatory Affairs Manager
Department: Quality/Regulatory
Reports To: Senior Director of RA
Work Location: East Brunswick, NJ

Position Summary:

Provide an overview of the role, including job scope / responsibilities, impact, decision authority, problem solving, level of influence, etc.

Essential Duties & Responsibilities: Rising owned ANDAs

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

Position Requirements:

Required: B.S. in Regulatory Affairs, Pharmacy, or Drug Regulatory Affairs
Required: 8-10 years’ experience within the pharmaceutical industry with minimum of 5+ years in Regulatory Affairs
Specialized Training or Technical Knowledge Licenses, Certifications Needed:
• Knowledge and comprehension of Code of Federal Regulations requirements (21CFR 211 GMP’s 21CFR 201 Labeling and 21 CFR 314 ANDA’s)

• Knowledge and comprehension of applicable FDA regulatory guidelines and compendia requirements

Company / Industry Related Knowledge:
Pharmaceutical knowledge

Job Specific Competencies:

• Working knowledge of MS Word, Excel, Outlook, and Power Point and Adobe Illustrator or equivalent
• Excellent communication and interpersonal skills

Physical Requirements:


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