Associate Director, Regulatory Affairs

Glenmark Pharmaceuticals • Elmwood Park, NJ

106d • $160,000 - $185,000

About The Position

The primary function of this position is to oversee a full portfolio of approved and unapproved ANDA products. The incumbent might also be designated as U.S. Agent (back-up) for the U.S. Office for both ANDAs (GPI USA) and API (GLS India). The position includes a number of responsibilities that will require excellent communication to support both internal and external customers (globally) including the U.S. FDA.

Requirements

• B.S. in Chemistry or Biology, or Engineering degree in Biotechnology or Chemical Engineering.
• Extensive experience in the pharmaceutical industry with at least 10+ years experience in regulatory affairs.
• Primary experience must be managing a significant number of generic drug products (ANDAs & OTCs).
• Capable and has the desire to manage direct reports, as assigned.

Nice To Haves

• Other experience in NDAs 505(b)(2) is a plus.

Responsibilities

• Manage at least one (1) and possibly up to (2) direct reports to ensure their assigned responsibilities are completed accurately and on a timely basis to support the needs of the business for internal/external customers.
• Support the U.S. Office for more than 170 approved ANDAs and all unapproved (under review ANDAs) as U.S. Agent back-up for all Glenmark subsidiaries including GPL, GSSA, GPI and GLS.
• Review and sign various submissions to FDA including ANDA cover letter, Form 356H for Original ANDAs, Amendments to ANDAs and/or Supplements to post-approval work.
• Provide support/RA strategy needed to achieve timely approvals with the Agency.
• Update the internal tracker that records all incoming and outgoing regulatory activities/communications for ANDAs/OTCs.
• Support OTC submissions, as needed, for ANDA conversion to OTC or OTC Monograph direct including any labeling reviews and updates.
• Ensure all manufacturing, packaging, labeling, testing and BA/BE sites are registered with FDA in the CDER Portal, as applicable.
• Ensure the payments are made on the scheduled due date to support all manufacturing sites.
• Submit all Recalls and FARS to FDA for ANDAs and OTCs, as needed to support commercial.
• Submit controlled correspondences for R&D through CDER NextGen Portal.
• Submit pre-ANDA Meeting Packages to FDA, as needed.
• Submit Responses to FDA Observations to support manufacturing sites, as needed.

Benefits

• Paid time off
• 401k plus company match
• Company paid health benefits
• Dental
• Vision
• Onsite access to company gym
• Paid Employee Referral Program
• EAP Employee Assistance Program
• Accident Insurance
• Critical Illness Insurance
• Short-Term Disability
• Life and AD & D Insurance
• Whole Life Insurance
• Pet Insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees