Role Overview

In this role, you will be a Regulatory lead for submission planning and submission strategy for development projects and existing (FDA Approved) products. You will be expected to prepare high quality ANDA submissions (including amendments, supplements and Annual Reports) with the support and oversight of the Senior Manager/Associate Director of Regulatory Affairs.

Primary Duties & Responsibilities

CMC Regulatory Affairs

• Act as the Regulatory Affairs lead on assigned projects ensuring the completion, accuracy and content of eCTD submissions (ANDAs, Supplements, Amendments and Annual Reports).
• Maintain and update senior Regulatory Affairs management of critical project updates and their potential impact to regulatory submissions, highlighting any potential challenges or issues that might arise through an FDA review.
• 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): 4 Years in the Generic Pharmaceutical Industry with at least 3 years in Regulatory Affairs
• Specific Knowledge: Regulatory Affairs general practices for generic drugs, FDA guidance's
• Travel: 5% (potential overseas travel to visit manufacturing sites/CMOs or CROs)
• 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.