Glenmark Pharmaceuticals Inc.
Associate Director, Regulatory Affairs
28 days ago
Elmwood Park
Job Description About the Job 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 Note: These statements are not intended to be an exhaustive list of all responsibilities and duties. • 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. It will include ANDA cover letter, Form 356H for Original ANDAs, Amendments to ANDAs and/or Supplements to post-approval work. Form 2252 for Annual Reports., • 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. The US Office is responsible to communicate these updates to the identified Sr. Management on a timely basis including R&D for unapproved products, RA India including post-approval team for post-approval activities. The email list is provided for such communications which includes Commercial Division Heads, R&D, QA, Legal, Business Development, Project Management, Demand Planning, Marketing and others identified on the list. It’s very important that these communications be shared with the FDA on a timely basis (typically the same day received from the FDA). Separate communications received from the FDA to support GLS will be sent to the GLS leadership team as identified., • 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 subsequent updates to Recalls / FARS to FDA on a timely basis to meet the required deadline., • 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 • 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., • Excellent communication skills including: verbal, reading and writing., • Use various labeling software tools such as TVT and/or Global Vision. Can be trained and have direct reports trained according to support labeling., • 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., • This will require direct prior experience doing the described activities., • It will in some instances require training, reading internal Standard Operating Procedures (SOPs), in-person training, and training by viewing FDA SBIA learning on-line video seminars or reading FDA guidance., • Read and understand current FDA guidance(s) and trends, USP general/specific DS/DP monographs, and be familiar with ICH guidelines and post-approval change guidance(s) accordingly., • Communicate with Supervisor and other Sr. Management on a timely basis when potential issues/concerns arise., • Use critical thinking skills and attention to detail is essential., • Ask questions and/or advice when in doubt., • The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties., • The noise level in the work environment is typical of that of an office, • Incumbent may encounter frequent interruptions throughout the workday. Salary Range - $160,000 – 185,000 The compensation range provided reflects the expected base compensation only and does not include potential bonuses, incentive plans, or benefits. An individual’s final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location. Benefits include: • 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 and so much more! About the Company Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people’s lives every day by helping to reduce their healthcare costs while delivering high-quality medicines. Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States. Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live. This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice. 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.
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