Associate Director, Regulatory Affairs

Job Description

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

Experience

Knowledge and Skills

Physical Demands and Abilities

Compensation and Benefits

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 :

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.