Associate Director, Regulatory Affairs

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 ResponsibilitiesManage 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 applicableEnsure 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 neededSubmit Responses to FDA Observations to support manufacturing sites, as neededQualificationsEducationB.S. in Chemistry or Biology, or Engineering degree in Biotechnology or Chemical EngineeringExperienceExtensive 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 SkillsExcellent 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 LabelingThe 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 pensation and BenefitsSalary Range - $160,000 – 185,000Benefits include:Paid time offCompany paid health benefitsVisionOnsite access to company gymPaid Employee Referral ProgramEAP – Employee Assistance ProgramCritical Illness InsuranceShort-Term DisabilityLife and AD & D InsuranceWhole Life InsurancePet InsuranceAbout the CompanyGlenmark 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. #J-18808-Ljbffr

Created: 2025-10-06