- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
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Description
Job Description
Job DescriptionSalary: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
Labeling and Promotional Review:
Regulatory-Operations:
Additional Duties & Responsibilities
Competencies/Career level
Innovation, entrepreneurial attitude, team leadership, adaptability/flexibility, results-oriented, Self-development.
Requirements and personal skills
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:
