Role Overview

In this role, you will be responsible for assisting the Senior Manager of Regulatory Affairs and other team members in various Regulatory-related tasks mentioned below.

Primary Duties & Responsibilities

CMC Regulatory Affairs

• Collaborate with different stakeholders of the company and procure documentation required for regulatory submissions, ensuring that departmental timelines are met.
• Support the creation and review of technical documents for accuracy and acceptability for use in new ANDAs, Amendments, Supplements, Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA.
• Review and approve change controls and assess their impact on the business based on an advanced understanding of regulatory guidelines and applicable FDA laws.

Labeling and Promotional Review:

• Preparation of various regulatory Labeling submissions
• Review and timely completion of labeling for ANDA dossiers for submissions and prepare and review response to labeling deficiencies to secure approval.
• Prepare and submit updated labeling in eCTD format to the FDA.
• Review labeling revisions and private label products.
• Initiate and provide approval for change controls related to Artwork and labeling.
• Ability to work on SPL Labeling

Regulatory-Operations:

• Manage tracking and filing FDA correspondence, including phone calls, emails, and relevant documents.
• Work with cross-functional teams to support regulatory activities for drug product submission.
• Accurately update and maintain spreadsheets and databases in a timely manner.
• Responsible for writing and/or reviewing Modules in eCTD and verifying proper hyperlinking and ensure navigational tools are functional.
• Publishing and compiling documents while maintaining adherence to FDA standards and internal requirements.
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.

Additional Duties & Responsibilities

• Trained and supports staff in the preparation of electronic drug listing information (SPL, PLR) to the FDA.
• Process documents, prepare, assemble, compile and publish regulatory submissions in Electronic Common Technical Documents format (eCTD) as required.

Competencies/Career level

Innovation, entrepreneurial attitude, team leadership, adaptability/flexibility, results-oriented, Self-development.

• Experienced user of various ECTD and SPL software
• Superior communication, research and writing skills.
• Attended a host of GMP training classes and Regulatory/Compliance Seminars and Webinars presented by professional organizations such as GPhA and RAPS affiliates.

Requirements and personal skills

• Education: Minimum of a bachelor’s degree in a life science, pharmacy-related curriculum and/ or Advanced degree related to Manufacturing, Chemical, Pharmaceutical, Biological- Sciences. (RAC- Certification is a plus)
• Languages: English, Spanish Language a Plus
• Experience (years/area): 2 Years in the Generic Pharmaceutical Industry with at least 1 year in Regulatory Affairs
• Specific Knowledge: Regulatory Affairs general practices for generic drugs, FDA guidance's
• Travel: Minimal
• Personal skills: General management skills, strong interpersonal and people development skills, strong results-orientation, superior leadership skills, ability to anticipate problems and solve them successfully.

Physical Demands

This job operates in a remotely in a professional environment. This role routinely uses standard office equipment such as computers, phones, printers, etc.

Travel: No

Position Type and Expected Hours of Work: This is a full-time position. Days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee:

• Is required to interact with internal and external contacts independently.
• Is regularly required to talk or hear either in person or over a dial tone phone, as well as a mobile phone, when applicable.
• Is desk-based and may be sitting for long periods of time. Ergonomically work from a chair for 8 hours per day.
• Constantly utilize a computer monitor screen, trying to minimize stress on vision.
• Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer)
• Must communicate clearly: phone calls, emails, in-person conversations.
• Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive functions.