Associate Director, Regulatory Affairs

Global Blockchain Talent; Elmwood Park (IL); On-site; USD 160,000 - 185,000; Full time

Job summary

A global pharmaceutical company in Elmwood Park, IL, is seeking a Regulatory Affairs Manager to oversee ANDA products and manage compliance with FDA regulations. The ideal candidate will have over 10 years of experience in the pharmaceutical industry, focusing on generic drugs. Responsibilities include managing regulatory submissions and direct reports. This position offers a competitive salary of $160,000 – 185,000 and comprehensive benefits including health insurance and paid time off.

Benefits

Paid time off

Company paid health benefits

Onsite access to company gym

Qualifications

• 10+ years of experience in regulatory affairs in the pharmaceutical industry.
• Experience managing generic drug products (ANDAs & OTCs).
• Proactive self-learner willing to understand FDA guidance.

Responsibilities

• Oversee a portfolio of ANDA products.
• Manage direct reports for completing responsibilities.
• Support U.S. FDA submissions and regulatory activities.

Skills

Excellent communication skills

Use various labeling software tools

Proficient using MS Word and Excel

Education

B.S. in Chemistry or Biology or Engineering

Tools

Drugs@FDA databases

USP database

Job description

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.

Job 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. The successful candidate will need to be able to review and sign various submissions to FDA.
• 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 which may include submissions to FDA and Corresponding Acknowledgements, ANDA Amendments and Responses to CRL (minor/major), DRLs and IRs.
• 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.
• Submission of PLAIRS accurately and timely as provided to the US Office.
• Shipping samples to the FDA for CDRH evaluation of devices.
• Submit pre-ANDA Meeting Packages to FDA, as needed
• Submit Responses to FDA Observations to support manufacturing sites, as needed

Qualifications

Education

• B.S. in Chemistry or Biology, or Engineering degree in Biotechnology or Chemical Engineering

Experience

• Extensive experience in the pharmaceutical industry with at least 10+ years’ experience in a regulatory affairs.
• Primary experience must be managing a significant number of generic drug products (ANDAs & OTCs).
• Capable and has the desire to manage at direct reports, as assigned.
• Other experience in NDAs 505(b)(2) is a plus.

Knowledge and Skills

• Excellent communication skills including: verbal, reading and writing.
• Use various labeling software tools such as TVT and/or Global Vision.
• Proficient using MS word, MS excel, reviewing Drugs@FDA databases, USP database, FDA Orange Book, DP Specifie Bioequivalence Guideline and Dailymed Labeling
• The successful candidate must be proactive in reading and understanding assigned materials including FDA guidance, 21 CFR, USP general chapters, USP specific monographs, and internal SOPs as assigned.
• The candidate must be a highly motivated, willing to be trained and be a self-learner in order to execute assigned tasks with attention to the details.

Compensation and Benefits

Salary Range - $160,000 – 185,000

Benefits include:

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

About the Company

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value.

Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.